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Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection in Women Undergoing Elective Cesarean Section

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202407629387640
Enrollment
283
Registered
2024-07-16
Start date
2023-02-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Interventions

Same glove during skin closure
Changing glove before skin closure

Sponsors

Ain Shams University Maternity Hospital and Adam International Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1-pregnant women aged 20-35 years; non-obese with body mass index (BMI) < 30 kg/m2 with term pregnancy = 37 weeks +0 days; singleton and viable fetuses were enrolled.

Exclusion criteria

Exclusion criteria: 1-obese women with body mass index (BMI) = 30 kg/m2. 2-anemic women with hemoglobin level < 10.5 g/dl 3-immuno-compromised women with medical disorders with pregnancy as diabetes mellitus, hypertension, cardiac, hepatic or renal disorders. 4- Women with anticipated pelvic adhesions as cases with history of endometriosis, pelvic inflammatory diseases or more than previous 3 CSs. 4- multifetal pregnancy 5- emergency CS, with antepartum hemorrhage (placenta previa or placenta accrete spectrum disorder). 6-obstetric cases with increased risk of infection as premature rapture of membranes (PROMs). 7- woman who refused to participate in the study or write consent

Design outcomes

Primary

MeasureTime frame
The primary outcome was the incidence of SSSI, which included wound seroma, wound hematoma wound infection, and skin separation.

Secondary

MeasureTime frame
The secondary outcomes were febrile morbidity, cellulitis, the prescription of antibiotics, period of hospital stay, and cost. Sample Size Justification: Using the EPI Info 7 software for sample size calculation, with a power of 80% and an alpha error of 0.05, and based on the study by Hameed et al. in 2020, the anticipated incidence of wound infection in the intervention group is 5% and in the control group is 18.8% [13]. A sample size of 100 women per group was necessary to detect the difference between the two groups. To account for an expected 10% loss of follow-up, the sample size was increased to 110 women per group. Group A, the intra-operative glove changing group, involves the surgeon replacing their outer surgical gloves with a new pair of sterile gloves just before abdominal closure. Meanwhile, Group B, the usual care group, entails the surgeon not changing their gloves before abdominal closure.

Countries

Egypt

Contacts

Public ContactAlaa ElDin;Ahmed ElFeky ;Sherif

lecturer obestatrics and gynecology Ain Shams University;Lecturer Obestatrics and Gynecology Ain Shams University

Fiky3487@gmail.com;cairotrade2050@gmail.com+201110600332;00966564820942

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026