Effectiveness of Glove Changing in Reducing Wound-related Complications

Wound Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748743
• Other study ID #: CK62721303
• Status: Completed
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: February 2023
• Source: Hung Vuong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Complication
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Vietnam	Hung Vuong hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Hung Vuong Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound complications	Seroma, hematoma, wound separation, and wound infection	Within 4 weeks after surgery
Secondary	Surgical site infection	Fever, swelling, redness, and pain surrounding the incisional area	Within 4 weeks after surgery