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Effectiveness of Glove Changing in Reducing Wound-related Complications

H

Hung Vuong Hospital

Status

Completed

Conditions

Wound Complication

Treatments

Procedure: glove changing

Study type

Interventional

Funder types

Other

Identifiers

NCT05748743
CK62721303

Details and patient eligibility

About

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

Full 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.

Enrollment

678 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

678 participants in 2 patient groups

Glove change group
Experimental group
Description:
The surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia
Treatment:
Procedure: glove changing
Usual care group
No Intervention group
Description:
The surgical gloves were not changed before abdominal closure

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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