Effectiveness of Glove Changing in Reducing Wound-related Complications

NCT05748743 | Completed

• 1 other identifier: CK62721303
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wound Complication

Keywords

Complications; Glove changing; Eesarean surgery; Infections; Vietnam

Outcome Measures

Primary Outcomes (1)

• Wound complications

  Seroma, hematoma, wound separation, and wound infection

  Within 4 weeks after surgery

Secondary Outcomes (1)

• Surgical site infection

  Within 4 weeks after surgery

Study Arms (2)

Glove change group

EXPERIMENTAL

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

Procedure: glove changing

Usual care group

NO INTERVENTION

The surgical gloves were not changed before abdominal closure

Interventions

glove changing PROCEDURE

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

Glove change group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We only recruited pregnant women to participate in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Infections

Study Officials

• Tuyet Hoang, Doctor

  Hung Vuong Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcomes assessor are blind to the intervention group assignment.The only people that were unmasked were the surgical team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: December 18, 2020
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)