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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Female Reproductive System Neoplasm

Intervention / Treatment
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* Procedure: Infection Prophylaxis and Management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Bathing Bundle)<br>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<br>* Undergo preoperative preparation with the Bathing Bundle<br>* Other names: Treatment of Infectious Disease;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Within 30 days following surgery |