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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.

Undergo preoperative preparation with the "Bathing Bundle"

Infection Prophylaxis and Management

Barbra Dodds

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.

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.

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

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.

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery	NCT01597804	Malignant Femal...	Infection Proph...	19 Years -	Roswell Park Cancer Institute
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery	NCT01597804	Malignant Femal...	Infection Proph...	19 Years -	Roswell Park Cancer Institute
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery	NCT01597804	Malignant Femal...	Infection Proph...	19 Years -	Roswell Park Cancer Institute
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery	NCT01597804	Malignant Femal...	Infection Proph...	19 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for infection prophylaxis and management