The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- The incidence of any post cesarean wound related complication
Study Overview
Brief Summary
The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.
Detailed Description
The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.
Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.
The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both elective and emergency cesarean sections.
- •Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.
Exclusion Criteria
- •Women with active infection during the procedure.
- •Women did not receive the standard preoperative antibiotic prophylaxis.
- •Women with diagnosis of chorioamnionitis.
Outcomes
Primary Outcomes
The incidence of any post cesarean wound related complication
Time Frame: 8 weeks
including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
khalid abd aziz mohamed
assistant professor
Benha University