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Completed

NCT Number: NCT05748743

Effectiveness of Glove Changing in Reducing Wound-related Complications

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hung Vuong hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glove changing

Procedure

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

Primary outcomes

  1. Wound complications

    Time frame: Within 4 weeks after surgery

    Seroma, hematoma, wound separation, and wound infection

Secondary outcomes

  1. Surgical site infection

    Time frame: Within 4 weeks after surgery

    Fever, swelling, redness, and pain surrounding the incisional area

Sponsors and collaborators

Lead sponsor

Hung Vuong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2023
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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