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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

infection prophylaxis and management

Procedure

Undergo preoperative preparation with the "Bathing Bundle"

Other names: Infectious Diseases / Treatment, General, infectious diseases treatment, management, infection prophylaxis, Treatment of Infectious Disease

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2016
First posted: May 14, 2012
Registry last updated: Jul 23, 2020

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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Completed