Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol

Drashti patel; Surekha Tayade

doi:10.12688/f1000research.140727.1

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Study Protocol

Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol

[version 1; peer review: 1 approved with reservations]

Drashti patel ¹, Surekha Tayade¹

PUBLISHED 23 Apr 2024

Author details Author details

¹ Obstetrics and gynecology, Jawaharlal nehru medical college, Datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India

Drashti patel
Roles: Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Surekha Tayade
Roles: Formal Analysis, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Surgical site infections (SSIs) pose a significant challenge in obstetric and gynaecological surgeries, with incidence rates ranging from 0.5% to 15%. These infections not only impact patient outcomes but also contribute to extended hospital stays and increased healthcare costs. To address this issue, a hospital-based interventional study is proposed, focusing on the implementation of a comprehensive quality improvement protocol within the Department of Obstetrics and Gynecology at Acharya Vinoba Bhave Rural Hospital (AVBRH), Wardha.

Methods

The study will include approximately 800 obstetric and gynaecological surgeries per year. Ethical approval has been obtained and written informed consent will be obtained from all enrolled women. The intervention involves the implementation of a surgical site infection prevention quality improvement protocol, encompassing elements such as standardized pre-operative antiseptic agents, proper cleaning procedures, and the use of injectable cefazolin. A structured proforma will be developed for data collection, covering demographic details, surgical parameters, surgeon characteristics, and post-operative outcomes.

Expected outcome

This study aims to assess the efficacy of the quality improvement protocol in reducing the incidence of surgical site infections. We anticipate that the implementation of this protocol will lead to a significant reduction in SSIs, improving patient outcomes and safety in obstetric and gynaecological surgeries. The study's findings will not only contribute to the body of knowledge on infection prevention but will also serve as a valuable framework for enhancing surgical safety in similar healthcare settings. Continuous evaluation and refinement of the protocol will be crucial for sustained success in reducing SSIs and improving overall patient care.

Keywords

Surgical site infections, Obstetrics and Gynaecology, surgical interventions

Corresponding author: Drashti patel

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 patel D and Tayade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: patel D and Tayade S. Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:365 (https://doi.org/10.12688/f1000research.140727.1) First published: 23 Apr 2024, 13:365 (https://doi.org/10.12688/f1000research.140727.1) Latest published: 23 Apr 2024, 13:365 (https://doi.org/10.12688/f1000research.140727.1)

Introduction

Infection occurring at the site of a surgical procedure is termed surgical site infection (SSI) and is a type of healthcare-associated infection.¹ Incisional infection is defined as an infection that extends from the incision site into the surrounding skin and subcutaneous tissue (superficial incisional infection), deeper soft tissues (such as fascia and muscle), or other anatomical structures (organ/space infection) within 30 days of surgery.²

Surgical site infections are prevalent, with rates varying from 0.5% to 15% depending on the procedure and the patient's overall health condition.³ This issue significantly undermines the effectiveness of surgical interventions and has notable impacts on post-operative expenses and length of hospital stay (3–20 days longer than anticipated).⁴^,⁵ Following abdominal surgery, environmental contamination, organisms on the patient's skin, or infectious sources within the abdominal cavity can lead to wound infections. Inadequate aseptic techniques by the surgical team, including the surgeon, or subsequent infection of a hematoma are also potential causes. Infection may occur anywhere, from a few days to a few weeks. The presence of an unexplained fever in a developing wound should always raise the suspicion of infection.⁶

Post-operative wound infection and dehiscence remain problematic after abdominal surgery, significantly prolonging hospitalization and causing psychological distress to patients and their relatives.⁷ Wound site infection, suture pressure, excessively tight sutures, wound trauma, weak tissue or muscle, improper suture techniques used for closure, high-dose or prolonged corticosteroid use, and severe vitamin C deficiency (scurvy) are common causes of wound dehiscence.⁸ Symptoms associated with wound infection and dehiscence include bleeding from the wound, pain at the suture site, swelling and redness near the suture site, fever, broken sutures, and in extreme cases, complete rupture of the incision with bowel protrusion through the abdominal wall. This critical condition is referred to as “burst abdomen” and requires immediate attention.⁹

Infection and disruption of surgical wounds have been linked to various factors, such as the presence of a previous scar or radiation at the incision site, failure to adhere to post-operative instructions (e.g., engaging in strenuous activity or lifting heavy objects too soon after surgery), surgical errors, and increased abdominal pressure due to factors such as fluid accumulation (ascites), bowel inflammation, severe coughing, straining, vomiting, and long-term use of corticosteroid medication.⁶

The implementation of preventive measures for surgical site infections, particularly through multimodal strategies, has proven effective in reducing both the frequency and burden of infections.¹⁰ For instance, there was a reported 17% decrease in SSI related to 10 selected procedures in the USA between 2008 and 2013, following improvement programs.¹¹ In African hospitals, a 60% reduction in SSI risk was observed after the implementation of a World Health Organization (WHO) multimodal strategy within the context of the WHO Surgical Unit-based Safety Programme (SUSP), which includes SSI surveillance.¹² The WHO strongly recommends surveillance and timely feedback of results, including SSI surveillance, as essential components of effective infection prevention and control (IPC) programs.¹⁰

Aim

This study is aimed to determine the efficacy of implementing quality improvement protocols in reducing the rate of surgical site infections among surgeries for gynecological or obstetrical indications.

Objectives

1) To study the incidence of surgical site infections following surgery for gynecological or obstetric indications.
2) To study the decrease in surgical site infections in gynecological and obstetric surgeries before and after implementation of the quality improvement protocol.
3) To study the effectiveness of the quality improvement protocol and timeline in which the reduction of infections occurs.

Methods

Research question

Does a surgical site infection prevention quality improvement protocol reduce surgical site infections among surgeries for gynecological or obstetrical indications as compared to those in the pre-protocol era in a tertiary care rural hospital?

Ethical approval

Ethical approval has been obtained from Institutional Ethics Committee (IEC) DMIMS (DU)/IEC/2022/113 Date-21/07/2022 and written informed consent from all enrolled women. This study is an analytical study based on behavioral intervention in the form of a standard infection prevention quality improvement protocol. The existing departmental protocol will be followed for the pre-protocol group; therefore, there will be no ethical issues. The ethical code of conduct will be followed, and the study subjects will not have any additional financial burden pertaining to the study. The CTRI Registration number is CTRI/2024/04/065567.

Study design

A hospital-based interventional study will be conducted in this study. The duration of the study will be two years.

Study location

The study will be conducted at the Department of Obstetrics and Gynecology, Acharya Vinoba Bhave Rural Hospital (AVBRH), Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha.

Study population

The study population will include women undergoing major abdominal surgery in Obstetrics and Gynecology, in the AVBRH hospital, Sawangi, Meghe, Wardha.

Inclusion criteria

1) Women of all age groups who underwent surgery for different obstetric or gynecological indications during the study period.
2) Women undergoing surgical procedures for gynecological/obstetrical indications in the operation theatre of the maternal and child wing of the study hospital.
3) Elective, as well as emergency surgical procedures, will be included.
4) Women consenting for inclusion in the study will be included.

Exclusion criteria

1) Women who recently operated at another hospital, were referred to the study hospital for complications and infection and require repeat surgery at the study hospital.
2) Women undergoing minor surgical procedures e.g., dilatation and curettage, polypectomy, and encirclage
3) Women undergoing surgeries by vaginal route.
4) Women undergoing perineal surgeries.
5) Women undergoing surgical procedures in the labour room.
6) Women who do not give consent for inclusion in study.

Study withdrawal criteria

1) Women unwilling to continue in study.
2) Women lost to follow-up after initial inclusion in study.

Intervention

The intervention will be in the form of a surgical site infection prevention quality improvement protocol, which will include the following steps:

a) Surgical hand scrubs according to WHO guidelines will be performed using soap and water with a standard timed technique for three minutes.²
b) Standard gloving procedure will be done according to WHO guidelines with standard technique.
c) Standardized pre-operative antiseptic agents and their application techniques will be used. Initial scrubbing of the abdomen with solution containing chlorhexidine gluconate, cetrimide, and isopropyl alcohol followed by solution containing chlorhexidine gluconate 2.5% and Ethyl alcohol will be conducted. This will be followed by the use of dry swab to clean the surgical area, followed by application of povidine iodine 5% solution with drying time of one minute and then draping will be commenced.
d) AST (Association of surgical Technologists) Standards of Practice for Surgical Drapes.¹³
e) Reducing traffic in operation theatre area and operation theatre
f) The use of injectable cefazolin 60 minutes prior to surgical incision in elective surgery and 30 minutes prior to surgery in emergency surgery will be performed.
g) Proper cleaning of operation theatre table after each surgery with carbonic acid will be performed.
h) Secondary dressing of the wound on day four in a sterile environment will be performed. The surgical site infection prevention quality improvement protocol module will be developed after discussion with the faculty and stakeholders of the Department of Obstetrics and Gynecology of the study hospital with inclusion of the above eight elements. Feedback will be obtained, and external and internal validity checks will be performed. Training of the surgical team, nursing team, aesthetic team, technicians, and attendants will be conducted in two batches regarding the implementation of the protocol in the study hospital.

Implementation will involve the following elements:

a) System change: Ensuring that the necessary infrastructure is in place to allow protocol at the point of care.
b) Training/Education of operation theatre staff.
c) Evaluation and feedback: Monitoring protocol implementation over a period of four weeks and ensuring compliance.
d) Reminders in the workplace with posters placed at appropriate place in operation theatre area.

Sample size

The Department of Obstetrics and Gynecology, AVBRH, Wardha, performs approximately 800 operations for obstetric and gynecological indications per year. The sample size is estimated based on the observations at the study hospital, in which prevalence of surgical site infections is approximately 4–5%. Following assumption of 95% confidence interval and 2% margin of error, sample size was calculated using the sample size formula.

N = \frac{Z_{1 - α / 2}^{2} * p * (1 - p)}{D^{2}} .

where z²1-α is the level of significance at 95% confidence interval =1.96

P = Infection rate =4–5% =0.04

D = desired error of margin =2% =0.02

Power of the test =80%

\begin{array}{c} n = {1.96}^{2} \times 0.04 \times (1 - 0.04) / {0.02}^{2} \\ = 202 \\ = 101 study subjects in each arm . \end{array}

Sampling technique

The study will consist of two arms: the pre-protocol arm and post-protocol arm.

Pre-protocol arm

In the pre-protocol arm, women requiring surgery who fulfil the inclusion and exclusion criteria will be enrolled as study subjects. Demographic information will be obtained. Physical examination, investigation and planning of surgery, anesthetic fitness, and posting the women for surgery will be performed by a team of doctors working in the maternal and child wing according to routine departmental protocols. Written informed consent will be obtained from each patient regarding the nature of surgery, indication for surgery, and benefits and risks involved in surgery, and written consent will be obtained for inclusion in the study. The existing departmental protocol for pre-operative skin preparation, draping, surgical technique, skin closure technique, and post-operative management will be followed until the patient is discharged. Study subjects will be monitored for evidence of surgical site infection by measuring the oral temperature every four hours and for clinical or bacteriological evidence of surgical site infection according to CDC definitions and guidelines.¹⁴^,¹⁵ A wound swab of the surgical site will be sent for culture and sensitivity testing in case of evidence of clinical sepsis. Total and differential leukocyte counts will be performed. All consecutive women fulfilling the inclusion criteria during the period of three months after the commencement of the study will be included in the pre-protocol arm.

Post-protocol arm

In the post-protocol arm, women requiring gynecological surgery who fulfill the inclusion and exclusion criteria will be enrolled as study subjects. The demographic details of the patients will also be obtained. Physical examination, investigation and planning of surgery, anesthetic fitness, and posting the women for surgery will be performed by a team of doctors working in the maternal and child wing according to routine departmental protocols. Written informed consent will be obtained from each patient regarding the nature of surgery, indication for surgery, and benefits and risks involved in surgery, and written consent will be obtained for inclusion in the study. The study subjects will undergo surgical procedures after ensuring compliance with the SSIPQI protocol at each step. Routine surgical technique, skin closure technique, and post-operative management will be followed until the patient is discharged. Study subjects will be monitored for evidence of surgical site infection by measuring the oral temperature every four hours and for clinical or bacteriological evidence of surgical site infection according to CDC definitions and guidelines.¹⁴^,¹⁵ Wound swabs of surgical sites will be sent for culture and sensitivity testing in cases of evidence of clinical sepsis. Total and differential leukocyte counts will be performed. All women fulfilling the inclusion criteria during the period of three months after ensuring compliance with the protocol will be included in the post-protocol arm. Further management of women with SSI will be performed according to standard departmental practice, without interference from the study. All study subjects from both the pre-protocol and post-protocol arms will be followed up at two weeks and four weeks after the surgical procedure.

Outcome measures

Data related to various outcome variables, such as demography, body mass index, associated medical, gynecological, and obstetrical risk factors; indication and nature of surgery-emergency or elective; duration of surgery; description of surgeon (postgraduate, junior consultant, senior consultant), skin closure technique, type of suture material for wound closure, intraoperative complications, need for blood transfusion, infective morbidity, surgical site infections, hospital stay, wound-related late complications, and mortality, if any, will be collected. A structured proforma will be developed, pilot-tested, validated, and used for data collection.

Statistical analysis

The data will be entered into a spreadsheet (Microsoft Excel 23) and transferred to SPSS version 23⁵ software. Student’s t-test will be used to test continuous variables that are normally distributed, and the Mann-Whitney test will be used to compare continuous variables with a skewed distribution. Proportions will be compared using the chi-squared test. Multivariate logistic regression models will be constructed to determine the independent association of prognostic factors. The strength of association will be expressed as odds ratios or risk ratios and their precision at 95% confidence intervals. A two-level P-value (<0.05) will be considered significant.

Operational definitions¹⁴^,¹⁵

Surgical site infection

An infection that develops within 30 days of surgery and spreads to the skin, subcutaneous tissue, and deeper soft tissues (such as fascia and muscle) of the incision, as well as to any other part of the body (such as organs and spaces) that were opened or manipulated during the procedure.²

Surgical wound

A surgical term for a wound that is caused by a scalpel or other sharp cutting device and then closed in the operating theatre using sutures, staples, adhesive tape, or glue to bring the cut edges of the skin together as closely as possible.

Febrile morbidities

Two occurrences of fever greater than 38 °C occurring at least four hours apart after the first 24 hours after surgery.

Surgical site sepsis: classified according to the presence of (a) redness and/or (b) swelling and/or (c) pus.

Wound dehiscence: Suture line separation of more than 1 cm, whether superficial, deep, or across the entire abdominal wall (burst abdomen), as defined by the Centers for Disease Control and Prevention.¹⁴

Superficial incisional surgical site infection

Within 30 days of surgery, the infection is limited to the skin and subcutaneous tissue of the incision, and at least one of the following conditions must be met: 1. Purulent drainage, with or without laboratory confirmation from the superficial incision; 2. organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision, 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and a superficial incision was deliberately opened by the surgeon, unless the incision was culture-negative, 4. Diagnosis of superficial incisional SSI by a surgeon or an attending physician.

Deep incisional surgical site infection

Infection that occurs within 30 days after the operation and involves deep soft tissue (e.g. fascia, muscle) of the incision and at least one of the following: 1. purulent drainage from the deep incision, but not from the organ/space component of the surgical site; 2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (>38°C), localized pain, or tenderness unless the incision is culture-negative, 3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination, 4. Diagnosis of deep incisional SSI by a surgeon or an attending physician.

Organ/space surgical site infection:

Infection that occurs within 30 days after the operation and appears to be related to the operation and infection involving any part of the anatomy (e.g., organs and spaces) other than the incision that was opened or manipulated during the operation and at least one of the following: 1. Purulent drainage from a drain was placed through a stab wound into the organ/space; 2. organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space, 3. an abscess or other evidence of infection involving the organ/space found on direct examination, during reoperation, or by histopathologic or radiologic examination, 4. Diagnosis of organ/space SSI by a surgeon or an attending physician.

Elective surgery

Elective surgery or elective procedure (from Latin: eligere, meaning to choose) is surgery that is scheduled in advance because it does not involve an emergency.

Emergency surgery

Surgery that must be performed without delay; the patient has no choice other than immediate surgery if they do not want to risk permanent disability or death.

Plans for dissemination

In anticipation of the study's completion, careful consideration has been given to the dissemination of both study outcomes and associated data to maximize the impact of our research. We recognize the importance of transparently sharing findings with the broader scientific community, healthcare practitioners, policymakers, and the public. The following outlines our comprehensive plan for dissemination:

Peer-reviewed journals

The primary vehicle for sharing our research findings will be through submission to reputable, peer-reviewed journals in the field. This ensures that our study undergoes rigorous evaluation and contributes to the existing body of knowledge.

Conference presentations

We aim to present our study at relevant national and international conferences, providing an opportunity for direct engagement with experts, fostering discussion, and receiving valuable feedback that could further enhance the interpretation of our results.

Educational workshops and seminars

We plan to organize workshops and seminars targeted at healthcare professionals, students, and researchers. These events will facilitate a more in-depth understanding of our study's methodology, results, and implications for clinical practice.

Online platforms and open access repositories

To ensure widespread accessibility, our research findings, accompanying datasets, and supplementary materials will be made available on recognized online platforms and open-access repositories. This approach aligns with our commitment to fostering transparency and enabling future researchers to build upon our work.

Collaboration with healthcare organizations

Collaboration with healthcare organizations will be sought to disseminate our findings directly to relevant stakeholders. This may include sharing summaries, infographics, or practical guidelines derived from our study with the aim of influencing clinical practices.

Social media engagement

Leveraging social media platforms will allow us to reach a broader audience, including patients, advocacy groups, and the general public. Regular updates, key findings, and infographics will be shared to enhance public understanding and engagement.

Policy briefs

Recognizing the potential impact of our study on healthcare policies, we plan to create concise policy briefs summarizing key findings. These documents will be strategically distributed to policymakers and relevant governmental bodies to inform evidence-based decision-making.

Collaboration with professional associations

We will actively engage with professional associations and societies related to our field of study to disseminate our research findings among their members. This collaboration will facilitate a targeted approach toward professionals who can directly incorporate our findings into their practices.

Study status

This study has not yet begun. After the protocol has been published, we will begin the study.

Discussion

the most prevalent nosocomial infection among surgical patients is a surgical site infection (SSI), constituting 15% of all nosocomial infections. Post-surgical infections increase the risk of complications, prolong recovery periods, escalate costs, and increase the chances of hospital readmission. In the majority of SSI cases, the source of infection stems from the native flora of the patient's skin, mucosal membranes, or hollow viscera.¹

Numerous independent studies have established a robust correlation between diabetes, smoking, obesity, and infections or colonization in remote sites, all of which contribute to an increased risk of SSI. Ideally, a skin microbial reduction chemical agent should possess the capability to eradicate all organisms on the skin, be non-toxic and hypoallergenic, prevent substantial systemic resorption, maintain efficacy over time, and be safe for repeated applications.

Antiseptics are categorized into three main groups: iodine/iodophor-, chlorhexidine-, and alcohol-based treatments. Surgical antiseptics containing iodine exhibit broad-spectrum efficacy, killing various bacteria including MRSA-resistant strains of Staphylococcus aureus, tubercle bacillus, yeasts, and viruses. However, caution is advised when administering iodine-based preparations to vulnerable populations, such as patients with severe burn patients and infants, as systemic absorption of iodine may occur, leading, in rare instances, to iodine toxicosis and death.

Chlorhexidine, which offers lower fungal coverage than iodophor- and alcohol-based solutions, is commercially available in both aqueous and alcohol-based formulations. It demonstrates extensive activity against gram-positive and gram-negative bacteria, anaerobes, yeast, and several lipid-enveloped viruses. Although alcohol is effective in rapidly killing bacteria, it loses its bactericidal properties when it evaporates. Often combined with iodine or chlorhexidine in surgical preparations, alcohol enhances the rate of bacterial death and prolongs the effects of other disinfectants.

The combination of chlorhexidine or iodine formulations with alcohol was more effective than formulations containing chlorhexidine or iodine alone. The effectiveness of various iodine, chlorhexidine, and alcohol families is influenced by factors such as concentration, temperature, acidity level, specific germ or virus, contact time, and whether the state is dry or wet.¹⁵^,¹⁶

Data availability

Underlying data

No data are associated with this article.

Extended data

Zenodo: Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol. https://doi.org/10.5281/zenodo.10576161.¹⁷

This project contains the following extended data:

- Tool.docx (Proforma to assess the data collection in the hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries)

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol’. https://doi.org/10.5281/zenodo.10146733.¹⁸

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References

1. Excellence NIfC: Surgical site infections: prevention and treatment. Clinical guidelines CG74.2008.
2. Organization WH: Global guidelines for the prevention of surgical site infection.2018.
3. Hajjar J, Savey A, Pinzaru G, et al.: Réseau ISO Sud-Est: un an de surveillance des infections du site opératoire. Bulletin épidémiologique hebdomadaire. 1996; 42: 183–185.
4. Brachman PS, Dan BB, Haley RW, et al.: Nosocomial surgical infections: incidence and cost. Surg. Clin. North Am. 1980 Feb 1; 60(1): 15–25. Publisher Full Text
5. Fabry J, Meynet R, Joron MT, et al.: Cost of nosocomial infections: analysis of 512 digestive surgery patients. World J. Surg. 1982 May; 6: 362–365. PubMed Abstract | Publisher Full Text
6. Probhakar P, Roje D, Castle D, et al.: Nosocomial surgical infections: incidence and cost in a developing country. Am. J. Infect. Control. 1983 Apr 1; 11(2): 51–56. Publisher Full Text
7. Kirkland KB, Briggs JP, Trivette SL, et al.: The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect. Control Hosp. Epidemiol. 1999 Nov; 20(11): 725–730. PubMed Abstract | Publisher Full Text
8. Chow TT, Yang XY: Ventilation performance in operating theatres against airborne infection: review of research activities and practical guidance. J. Hosp. Infect. 2004 Feb 1; 56(2): 85–92. PubMed Abstract | Publisher Full Text
9. Hoffman PN, Williams J, Stacey A, et al.: Microbiological commissioning and monitoring of operating theatre suites. J. Hosp. Infect. 2002 Sep 1; 52(1): 1–28.
10. Scott RD: The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention.2009
11. DeFrances CJ, Podgornik MN: 2004 national hospital discharge survey. Adv. Data. 2006; 371: 1–19.
12. Sopirala MM, Syed A, Jandarov R, et al.: Impact of a change in surveillance definition on performance assessment of a catheter-associated urinary tract infection prevention program at a tertiary care medical center. Am. J. Infect. Control. 2018 Jul 1; 46(7): 743–746. PubMed Abstract | Publisher Full Text
13. Yumpu.com: AST Recommended Standards of Practice for Surgical Drapes. Accessed: January 28, 2024. Reference Source Reference Source
14. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al.: Centers for disease control and prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg. 2017 Aug 1; 152(8): 784–791. PubMed Abstract | Publisher Full Text
15. Horan TC, Gaynes RP, Martone WJ, et al.: CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect. Control Hosp. Epidemiol. 1992 Oct; 13(10): 606–608. PubMed Abstract | Publisher Full Text
16. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al.: Centers for disease control and prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg. 2017 Aug 1; 152(8): 784–791. PubMed Abstract | Publisher Full Text
17. Drashti P: Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol. [Dataset]. Zenodo. 2024. Publisher Full Text
18. Sindhuja BG: Reporting guidelines of "Prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India". [Dataset]. Zenodo. 2023. Publisher Full Text

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Author details Author details

¹ Obstetrics and gynecology, Jawaharlal nehru medical college, Datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India

Drashti patel
Roles: Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Surekha Tayade
Roles: Formal Analysis, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

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Published: 23 Apr 2024, 13:365

https://doi.org/10.12688/f1000research.140727.1

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© 2024 patel D and Tayade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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patel D and Tayade S. Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:365 (https://doi.org/10.12688/f1000research.140727.1)

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Reviewer Report 03 Jan 2025

Prakash Kumar Sasmal, Department of Surgery, AIIMS, Bhubaneswar, India

Approved with Reservations

https://doi.org/10.5256/f1000research.154114.r351523

The abstract could be improved by Including the study design explicitly (e.g., prospective interventional study with pre-and post-intervention evaluation).
Specify why Acharya Vinoba Bhave Rural Hospital (AVBRH) was chosen for the study. For instance, mention

The abstract could be improved by Including the study design explicitly (e.g., prospective interventional study with pre-and post-intervention evaluation).
Specify why Acharya Vinoba Bhave Rural Hospital (AVBRH) was chosen for the study. For instance, mention historical SSI rates, if available. Mention gaps in current practices or standards at AVBRH that the quality improvement protocol aims to address.
Clearly describe the protocol's novelty or customization compared to standard WHO or CDC guidelines for SSI prevention. Specify how adherence to the protocol will be ensured and monitored during implementation.
Ethics: Include provisions for patient confidentiality and secure data handling
The outcomes need to be divided into:

Primary Outcome:
The primary outcome (reduction in SSI incidence) is highly relevant and appropriately focused.

Secondary Outcomes:
Consider adding outcomes such as:

Length of hospital stay.
Cost reduction associated with fewer SSIs.
The compliance rate with the protocol among surgical teams.

Expected Outcome: Include specific metrics for evaluating success, such as the targeted percentage reduction in SSI rates within a set timeframe. For clarity, organize into subcategories (e.g., Demographics, Operative Factors, Post-operative Factors).

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: General Surgery, Gastrointestinal, Endocrine and Metabolic diseases.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Approved With Reservations

The abstract could be improved by Including the study design explicitly (e.g., prospective interventional study with pre-and post-intervention evaluation).
Specify why Acharya Vinoba Bhave Rural Hospital (AVBRH) was chosen for the study. For instance, mention historical SSI rates, if available. Mention gaps in current practices or standards at AVBRH that the quality improvement protocol aims to address.
Clearly describe the protocol's novelty or customization compared to standard WHO or CDC guidelines for SSI prevention. Specify how adherence to the protocol will be ensured and monitored during implementation.
Ethics: Include provisions for patient confidentiality and secure data handling
The outcomes need to be divided into:

Primary Outcome:
The primary outcome (reduction in SSI incidence) is highly relevant and appropriately focused.

Secondary Outcomes:
Consider adding outcomes such as:

Length of hospital stay.
Cost reduction associated with fewer SSIs.
The compliance rate with the protocol among surgical teams.

Expected Outcome: Include specific metrics for evaluating success, such as the targeted percentage reduction in SSI rates within a set timeframe. For clarity, organize into subcategories (e.g., Demographics, Operative Factors, Post-operative Factors).

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

General Surgery, Gastrointestinal, Endocrine and Metabolic diseases.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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[17] 17. Drashti P: Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol. [Dataset]. Zenodo. 2024. Publisher Full Text

[18] 18. Sindhuja BG: Reporting guidelines of "Prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India". [Dataset]. Zenodo. 2023. Publisher Full Text

Hospital based interventional study implementation of supervised quality improvement protocol in reducing surgical site infections in obstetrics and gynaecological major surgeries: A study protocol

Abstract

Background

Methods

Expected outcome

Keywords

Introduction

Aim

Objectives

Methods

Research question

Ethical approval

Study design

Study location

Study population

Intervention

Sample size

Sampling technique

Outcome measures

Statistical analysis

Operational definitions14,15

Plans for dissemination

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

References

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