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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01597804
First received: May 10, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The nurses at Roswell Park Cancer Institute are conducting a study to see if the way patients wash before surgery and the soap they use will help reduce the rate of surgical site infection. Every gynecology surgical patient scheduled for abdominal surgery will be given a "Bathing Bundle" to use for washing the night before and the morning of their surgery. The "Bathing Bundle" contains an antimicrobial skin cleanser solution (chlorhexidine gluconate solution 4.0% [CHG]) and disposable wash clothes for the patient to bathe or shower with the night before and the morning of surgery. There are specific instructions in the "Bathing Bundle" that you will need to follow. Research has shown that CHG has helped to reduce the level of bacteria on the skin surface for some patients. The current preoperative standard of care instructs the patient to use an antibacterial soap instead of the skin cleanser provided in the "Bathing Bundle". Our research will compare patients that use the "Bathing Bundle" with 4% chlorhexidine gluconate to patients that use the standard of care anti-bacterial soap (i.e. Dial Soap)


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

Resource links provided by NLM:


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 between July 1, 2008 and July 1, 2010 [ Time Frame: Within 30 days following surgery ] [ Designated as safety issue: No ]
    Assessed using Fisher™s exact test. With 400 patients in each group and a two-sided significance level of 0.05, it has 80% power to detect 5.9 percentage point decline in SSI rate, assuming SSI rate among historical controls is 12%. Supplemented by logistic regression modeling for probability of SSI given bathing regimen used, controlling for compliance and other characteristics of interest. Pre- and post intervention patient samples compared on various demographic, health behavior, and disease characteristics. Descriptive statistics and various graphical displays provided as appropriate


Enrollment: 409
Study Start Date: April 2011
Primary Completion Date: February 2014 (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:

PRIMARY OBJECTIVES:

I. To investigate whether gynecology surgical patients using a Bathing Bundle using CHG 4% skin prep solution 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 during 2009 & 2010.

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597804

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01597804     History of Changes
Other Study ID Numbers: I 189910, NCI-2012-00273
Study First Received: May 10, 2012
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 16, 2014