NCT01597804

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

A "Bathing Bundle" Regimen to Reduce the Risk of Gynecological Surgical Site Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Female Reproductive System Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Infection Prophylaxis and Management	Undergo preoperative preparation with the "Bathing Bundle"

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-02-01
• Completion: 2016-04-01
• First posted: 2012-05-14
• Last updated: 2020-07-23

Locations

1 site across 1 country: United States