Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery
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Purpose
The nurses at Roswell Park Cancer Institute are conducting a study to see if the way patients wash before surgery and the soap they use will help reduce the rate of surgical site infection. Every gynecology surgical patient scheduled for abdominal surgery will be given a "Bathing Bundle" to use for washing the night before and the morning of their surgery. The "Bathing Bundle" contains an antimicrobial skin cleanser solution (chlorhexidine gluconate solution 4.0% [CHG]) and disposable wash clothes for the patient to bathe or shower with the night before and the morning of surgery. There are specific instructions in the "Bathing Bundle" that you will need to follow. Research has shown that CHG has helped to reduce the level of bacteria on the skin surface for some patients. The current preoperative standard of care instructs the patient to use an antibacterial soap instead of the skin cleanser provided in the "Bathing Bundle". Our research will compare patients that use the "Bathing Bundle" with 4% chlorhexidine gluconate to patients that use the standard of care anti-bacterial soap (i.e. Dial Soap)
| Condition | Intervention |
|---|---|
|
Female Reproductive Cancer |
Procedure: infection prophylaxis and management |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A "Bathing Bundle" Regimen to Reduce the Risk of Gynecological Surgical Site Infection |
- 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 [ Time Frame: Within 30 days following surgery ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Procedure: infection prophylaxis and management
Undergo preoperative preparation with the "Bathing Bundle"
Other Name: treatment of infectious disease
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Roswell Park 716-845-4096 AskRPCI@Roswellpark.org | |
| Principal Investigator: Darryl D. Somayaji | |
| Principal Investigator: | Darryl Somayaji | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01597804 History of Changes |
| Other Study ID Numbers: | I 189910, NCI-2012-00273 |
| Study First Received: | May 10, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013