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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01597804
Collaborator
(none)
435
Enrollment
1
Location
1
Arm
60
Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Infection Prophylaxis and Management
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
435 participants
Allocation:
N/A
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 :
Apr 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes 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

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Barbra Dodds, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01597804
    Other Study ID Numbers:
    • I 189910
    • NCI-2012-00273
    • I 189910
    First Posted:
    May 14, 2012
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Surgical Wound Infection
    Genital Neoplasms, Female

    Study Results

    No Results Posted as of Jul 23, 2020