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


N/A
19 Years
N/A
Open (Enrolling)
Female
Female Reproductive Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. To investigate whether gynecology surgical patients using a Bathing Bundle using CHG 4%
skin prep solution 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 during 2009 & 2010.

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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Presence of a site infection, compared with historical SSI rates among RPCI GYN surgery patients treated with the standard of care between July 1, 2008 and July 1, 2010

Outcome Description:

Assessed using Fisher™s exact test. With 400 patients in each group and a two-sided significance level of 0.05, it has 80% power to detect 5.9 percentage point decline in SSI rate, assuming SSI rate among historical controls is 12%. Supplemented by logistic regression modeling for probability of SSI given bathing regimen used, controlling for compliance and other characteristics of interest. Pre- and post intervention patient samples compared on various demographic, health behavior, and disease characteristics. Descriptive statistics and various graphical displays provided as appropriate

Outcome Time Frame:

Within 30 days following surgery

Safety Issue:

No

Principal Investigator

Darryl Somayaji

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

I 189910

NCT ID:

NCT01597804

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Female Reproductive Cancer

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263