Effectiveness of Glove Changing in Reducing Wound-related Complications

February 28, 2023 updated by: Tri Bao Nguyen, Hung Vuong Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

678

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Hung Vuong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hung Vuong Hospital

Investigators

  • Study Director: Tuyet Hoang, Doctor, Hung Vuong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK62721303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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