The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication

Study Overview
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Brief Summary
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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
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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

Official Title
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The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial

Conditions
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Decreasing Wound Infection

Intervention / Treatment
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* Other: changing surgical gloves


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Other: changing surgical gloves<br>* All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.<br>|
| No Intervention: Group B<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of any post cesarean wound related complication | including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment | 8 weeks |