Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hung Vuong Hospital
- Enrollment
- 678
- Locations
- 1
- Primary Endpoint
- Wound complications
Study Overview
Brief Summary
This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants, investigators, and outcomes assessor are blind to the intervention group assignment.The only people that were unmasked were the surgical team.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Wound complications
Time Frame: Within 4 weeks after surgery
Seroma, hematoma, wound separation, and wound infection
Secondary Outcomes
- Surgical site infection(Within 4 weeks after surgery)
Investigators
Tri Bao Nguyen
Principle investigator
Hung Vuong Hospital