N/A
N=81
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients
Postoperative Complications · Obesity · Gynecologic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02309944 ↗Enrolled (actual)
81
Serious AEs
29.6%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) — 25; 33; 12; 9 Participants — p=0.27
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Wound Closure (Procedure); Prevena™ Incision Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) |
25; 33; 12; 9 | 0.27 |
| SECONDARY Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies |
37; 28 | — |
Summary
The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.
Eligibility Criteria
Inclusion Criteria
- Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned
- Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record
Exclusion Criteria
- Known true tape allergy
- Sensitivity to silver
- History of intolerance to Negative Pressure Wound Therapy
Data sourced from ClinicalTrials.gov (NCT02309944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.