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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Malignant Female Reproductive System Neoplasm

Treatments: Procedure: Infection Prophylaxis and Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01597804

NCI-2012-00273 (Registry Identifier)

I 189910 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 435 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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435 participants in 1 patient group

Supportive care ("Bathing Bundle")

Experimental group

Description:

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.

Treatment:

Procedure: Infection Prophylaxis and Management