Effectiveness of Glove Changing in Reducing Wound-related Complications

Study Overview
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Brief Summary
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This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.

Detailed Description
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In Vietnam, the rate of Cesarean section (CS) is very high, ranging from 40-50%. Despite that, there are very limited publications concerning the risk factors, complications, and management of surgical site infection (SSI) following CS. Our study is the first to investigate the effectiveness of glove changing in reducing the incidence of post-operative infections in Vietnam. Specifically, the aims of this study are 1) to evaluate whether changing gloves during CS reduces complications and SSI, and 2) to identify other factors that are associated with complications and SSI.

Official Title
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Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam

Conditions
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Wound Complication

Intervention / Treatment
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* Procedure: glove changing


Participation Criteria
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Eligibility Criteria
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Inclusion criteria pregnant women were 18 years old or higher; pregnant women had cesarean surgery performed at Hung Vuong hospital; pregnant women lived close to Ho Chi Minh city and agreed to return for postpartum care one-month post-surgery. Exclusion criteria pregnant women had fever during labor; pregnant women had systemic infectious conditions; pregnant women had surgical site infection SSI or sexually infectious conditions; pregnant women had ongoing internal conditions such as pre-eclampsia, severe anemia, American Society of Anesthesiologists (ASA) ≥ 3, New York Heart Association (NYHA) class 3 or above, pulmonary edema, or severe asthma.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will have glove changed prior to abdominal closure during cesarean surgery. Aim 2 includes patients who will not have glove changed prior to abdominal closure during cesarean surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. Clinic visits are performed at 2 time points. Visit 1 is at 2-3 days post-surgery and visit 2 is at 30 ± 2 days post-surgery where primary and secondary outcomes are measured. The primary outcomes of interest are any wound complications occurring after the surgery, including seroma, hematoma, wound separation, and wound infection. Secondary outcomes are any signs of SSI, including fever, swelling, redness, and pain surrounding the incisional area. The outcomes will be evaluated during clinic visits by qualified medical practitioners who are blind to the intervention group assignment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glove change group<br>The surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia | Procedure: glove changing<br>* Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery<br>|
| No Intervention: Usual care group<br>The surgical gloves were not changed before abdominal closure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications | Seroma, hematoma, wound separation, and wound infection | Within 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Fever, swelling, redness, and pain surrounding the incisional area | Within 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications, Glove changing, Eesarean surgery, Infections, Vietnam