Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: May 10, 2012
Last updated: January 5, 2015
Last verified: January 2015

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.

Condition Intervention
Female Reproductive Cancer
Procedure: infection prophylaxis and management

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A "Bathing Bundle" Regimen to Reduce the Risk of Gynecological Surgical Site Infection

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 609
Study Start Date: April 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care ("Bathing Bundle")
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.
Procedure: infection prophylaxis and management
Undergo preoperative preparation with the "Bathing Bundle"
Other Name: treatment of infectious disease

Detailed Description:


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).


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.


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01597804

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Barbra Dodds Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01597804     History of Changes
Other Study ID Numbers: I 189910, NCI-2012-00273, I 189910, P30CA016056
Study First Received: May 10, 2012
Last Updated: January 5, 2015
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015