Clinical trial NCT05748743: Effectiveness of Glove Changing in Reducing Wound-related Complications
Official title: Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Complication
Keywords: Complications
Glove changing
Eesarean surgery
Infections
Vietnam
Lead sponsor: Hung Vuong Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 678
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound complications
timeFrame: Within 4 weeks after surgery
Secondary outcomes:
measure: Surgical site infection
timeFrame: Within 4 weeks after surgery
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong hospital
Study officials:
affiliation: Hung Vuong Hospital
name: Tuyet Hoang, Doctor
role: STUDY_DIRECTOR
References: