Malignant Female Reproductive System Neoplasm
Conditions
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.
Detailed 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.
Interventions
PROCEDUREInfection Prophylaxis and Management
Undergo preoperative preparation with the Bathing Bundle
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Within 30 days following surgery | 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. |
Countries
United States
Outcome results
None listed