Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery

Not Applicable

Completed

• Conditions: Malignant Female Reproductive System Neoplasm

• Registration Number: NCT01597804
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk of wound infection, extended length of hospital stay, readmission into the hospital, and the overall healthcare costs in patients undergoing surgery.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate whether gynecology surgical patients using a Bathing Bundle using chlorhexidine gluconate (CHG) 4% skin prep solution (Intervention Group A) have a lower incidence of surgical site infection (SSI) than patients treated with the current standard of care (patient's choice of antibacterial soap). Standard of care results will be based on historical information gathered on Roswell Park Cancer Institute (RPCI) gynecology (GYN) patients prior to July 1, 2010 (Historical Control Group B).

OUTLINE:

Patients undergo preoperative preparation with the "Bathing Bundle" comprising CHG 4% skin prep solution and disposable wash cloths to bathe or shower with the night before and morning of surgery.

After completion of study treatment, patients are followed up for 2 years.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Primary Completion: 2014-02
• Study Completion: 2016-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 435

Inclusion Criteria

• GYN surgical patients scheduled for abdominal surgery

Exclusion Criteria

• Patients with known hypersensitivity to chlorhexidine
• GYN non-surgical patients or surgical patients that will not have an abdominal incision (i.e. vaginal procedures)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Presence of a site infection, compared with historical SSI rates among RPCI GYN surgery patients treated with the standard of care before July 1, 2010	Within 30 days following surgery	Assessed using Fisher's exact test. This primary analysis will be supplemented by logistic regression modeling for the probability of an SSI given the bathing regimen used, controlling for compliance and other patient characteristics of interest. The pre- and post intervention patient samples will be compared on various demographic, health behavior, and disease characteristics. Descriptive statistics and various graphical displays will be provided as appropriate.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States