Effectiveness of Glove Changing in Reducing Wound-related Complications

Sponsor

Hung Vuong Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05748743

Collaborator

(none)

678

Enrollment

Location

Arms

2.3

Actual Duration (Months)

299.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Wound Complication	Procedure: glove changing	N/A

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

Actual Enrollment :

678 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 18, 2020

Actual Primary Completion Date :

Feb 25, 2021

Actual Study Completion Date :

Feb 25, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Glove change group

The surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia

Procedure: glove changing

Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery

No Intervention: Usual care group

The surgical gloves were not changed before abdominal closure

Outcome Measures

Primary Outcome Measures

Wound complications [Within 4 weeks after surgery]
Seroma, hematoma, wound separation, and wound infection

Secondary Outcome Measures

Surgical site infection [Within 4 weeks after surgery]
Fever, swelling, redness, and pain surrounding the incisional area

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.