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

NCT01597804 | Completed

• 2 other identifiers: I 189910NCI-2012-00273
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

Supportive care ("Bathing Bundle")

EXPERIMENTAL

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

Interventions

Infection Prophylaxis and Management PROCEDURE

Undergo preoperative preparation with the "Bathing Bundle"

Also known as: Infectious Diseases / Treatment, General, infectious diseases treatment, management, infection prophylaxis, Treatment of Infectious Disease

Supportive care ("Bathing Bundle")

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GYN surgical patients scheduled for abdominal surgery

You may not qualify if:

• Patients with known hypersensitivity to chlorhexidine
• GYN non-surgical patients or surgical patients that will not have an abdominal incision (i.e. vaginal procedures)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Barbra Dodds

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2016
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)