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Completed

NCT Number: NCT02907892

Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial

A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

Completed

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

About this study

This was a randomized, single-blind controlled trial of women who underwent cesarean section at Healthpartners Regions Hospital. Potential participants were identified during routine obstetrical care of singleton pregnancies at Regions Hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. Patients were excluded if the cesarean section was performed emergently. Randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. Patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. Patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section

Exclusion criteria

  • Severe immunocompromise (AIDS) or emergent nature of cesarean section

Treatment and study plan

Glove change

Procedure

Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Primary outcomes

  1. Composite Wound Complication

    Time frame: Within 8 weeks following cesarean section

    Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • HealthPartners Institute

Registry information

Official study title

Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
Aug 17, 2018

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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