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

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ClinicalTrials.gov Identifier: NCT01597804
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Female Reproductive System Neoplasm Procedure: Infection Prophylaxis and Management Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A "Bathing Bundle" Regimen to Reduce the Risk of Gynecological Surgical Site Infection
Study Start Date : April 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2016

Arm Intervention/treatment
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 Names:
  • Infectious Diseases / Treatment, General
  • infectious diseases treatment
  • management, infection prophylaxis
  • Treatment of Infectious Disease




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597804


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbra Dodds Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01597804     History of Changes
Other Study ID Numbers: I 189910
NCI-2012-00273 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 189910 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Surgical Wound Infection
Genital Neoplasms, Female
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Urogenital Neoplasms
Neoplasms by Site
Neoplasms