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Completed

NCT Number: NCT02902419

The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Peter's Hospital, Albany, New York, United States

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About this study

A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients ages 18-50 years;
  • medically competent (no proxies or prisoners); and
  • multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.

Exclusion criteria

  • Inability to obtain informed consent;
  • fetal death;
  • immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.

Treatment and study plan

Wound dressing removal.

Other

Primary outcomes

  1. Surgical Site infection Rate

    Time frame: 6 weeks postoperatively

    Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2016
Registry last updated
Sep 15, 2016

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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