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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Malignant Female Reproductive System Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Infection Prophylaxis and Management

Intervention Type PROCEDURE

Undergo preoperative preparation with the "Bathing Bundle"

Interventions

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Infection Prophylaxis and Management

Undergo preoperative preparation with the "Bathing Bundle"

Intervention Type PROCEDURE

Other Intervention Names

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Infectious Diseases / Treatment, General infectious diseases treatment management, infection prophylaxis Treatment of Infectious Disease

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)

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No