The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
I. To determine whether negative pressure therapy applied to closed laparotomy incisions can
decrease the incidence of incisional surgical site infections in patients undergoing
clean-contaminated resections for colorectal, pancreatic, and peritoneal surface
malignancies compared to standard post-operative sterile gauze dressings.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy
incision at the conclusion of their surgery.
ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed
laparotomy incision at the conclusion of their surgery.
After completion of study treatment, patients are followed up at 30 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|