- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06257940
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection
February 6, 2024 updated by: Naglaa Hamada Mohamed, Assiut University
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection in Women Undergoing Elective Cesarean Section; a Prospective Randomized Controlled Clinical Trial
Assessment of the impact of changing sterile gloves at the time of wound closure on reduction of SSI in women undergoing elective CS.
Study Overview
Status
Recruiting
Conditions
Detailed Description
- CS is the most common major operation preformed worldwide. In daily obstetric practice. It account for up to 60% of all births in some countries .
- Previous study reported that Egypt has the third highest CS rate (54%) in the world and lacks a standard classification system to analyze CS rates, following Do-minican Republic (56.4 percent) and Brazil (55.6 percent). Within the Arab region, rates of CS are far higher in Egypt than any other Arab country .
- In another study, the CS rate in Egypt was estimated at 55.1%, and the highest rate was 67.8% in Behira and the lowest was 49.0% in Assiut. In most governorates, the CS rate was higher in rural than in urban areas, but the difference was not significant. High CS rates were significantly related to higher social class and lower number of children (≤ 3).
- The percentage of "unjustified" caesarean deliveries has exceeded 62 percent of total deliveries in Egypt, many of which could have been done naturally. In August 2022, the Central Agency for Public Mobilization and Statistics (CAPMAS) reported a noticeable increase in C-sections in recent years. CAPMAS found that C-sections increased to 72 percent of all deliveries in 2021, up from 52 percent in 2014. The agency also found that C-sections in rural areas increased to 84 percent of all deliveries in 2021, up from 70.6 percent in 2014.
- One of the most serious complications after CS is wound complication it varies from 3 to 30% .
- It may be infectious as SSI or non-infectious as hematoma, seroma, and wound separation. These complications cause increase hospital stay or readmission also, maternal morbidaty and cost are increased .
- SSIs are a common cause of health care-associated infection. The United States Centers for Disease Control and Prevention (CDC) has developed criteria that define SSI as infection related to an operative procedure that occurs at or near the surgical incision within 30 days of the procedure or within 90 days if prosthetic material is implanted at surgery. SSIs are often localized to the incision site (superficial/deep incisional SSI) but can also extend into deep tissues .
- There were numerous recommendations for SSI prevention efforts in recent World Health Organization (WHO) guidelines, however most of these interventions were not well-supported by high-quality evidence .
- WHO recommendations for change of gloves at the time of fascial closure were identified as the priority recommendations. Three studies have been published to date, all suggesting to a benefit, however the particular evidence for SSI reduction with glove change prior to fascial closure is limited, consisting primarily of small RCTs with a high risk of bias .
- The CDC, WHO, and NICE guidelines do not recommend changing gloves as part of routine care due to the poor evidence data base. The executive summary of the 2017 WHO Guidelines on SSI Reduction Practice indicates that well-designed RCTs would be requested because there is no direct proof of the usefulness of sterile surgical gloves changing prior to wound closure .
- The CDC healthcare-associated infection (HAI) prevalence survey found that there were an estimated 110,800 SSIs associated with inpatient surgeries in 2015. SSI is the most costly HAI type with an estimated annual cost of $3.3 billion, and extends hospital length of stay by 9.7 days, with cost of hospitalization increased by more than $20,000 per admission
Study Type
Observational
Enrollment (Estimated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: : Naglaa Hamada Mohamed Ahmed, master
- Phone Number: +201151786690
- Email: drnaglaahamada@gmail.com
Study Contact Backup
- Name: Ahmed Mohamed Ali Nasr, professor
- Phone Number: 01005212140
- Email: ahmedmanasr@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut University
-
Contact:
- Ahmed Abu El-Fadl El-Sayed, assistant professor
- Phone Number: 01028807092
- Email: drahmedmohamed83@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
study will be conducted in Assuit Women Health Hospital We will recruit a pregnant women attending for cesarean sections according to the previous inclusion and exclusion criteria.
Description
Inclusion Criteria:
- Age: 20-35 years.
- Non obese with body mass index (BMI) < 30 kg/m2.
- Term pregnancy ≥ 37 weeks +0 days.
- Singleton.
- Viable fetus.
Exclusion Criteria:
- Obese women with body mass index (BMI) ≥ 30 kg/m2.
- Anemic women with hemoglobin level < 10.5 g/dl.
- Immuno-compromised women with medical disorders with pregnancy as diabetes mellitus, hypertension, cardiac, hepatic or renal disorders.
- Women with anticipated pelvic adhesions as cases with history of endometriosis, pelvic inflammatory diseases or more than previous 3 CSs.
- Multifetal pregnancy.
- Emergency CS.
- Women with antepartum hemorrhage (placenta previa or placenta accrete spectrum disorder).
- Obstetric cases with increased risk of infection as premature rapture of membranes (PROMs).
- Women refusing to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
intra-operative glove changing group
in which, the surgeon will replace his/her outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure
|
usual care group
in which, surgeon won't change his/her gloves before abdominal closure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection
Time Frame: within 4 weeks after cesarean sections
|
Composite end point of any wound complication i.e.
SSI occurring within one and three weeks following delivery.
These wound complications include wound seroma, wound hematoma, wound infection, skin separation of at least 1 cm or other incisional abnormality requiring a bedside procedure to treat.
|
within 4 weeks after cesarean sections
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed Abu El-Fadl El-Sayed, assistant professor, obstetrics & gynacology depatmen assiut university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029. Epub 2016 Nov 30. No abstract available.
- Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
- Wahdan M, Hakim S, El Gaafary M, Sos D, Wassif G, Hussein W, Mokhtar A, Hussein A, El Awady M, Rady M, Anwar W. Rising trends in Caesarean section in 6 Egyptian governorates. East Mediterr Health J. 2022 May 29;28(5):336-344. doi: 10.26719/emhj.22.012.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 14, 2024
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2023-200359
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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