Phase 4
N=140
A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications
Wound Infection · Peripheral Arterial Disease · Aneurysm · Surgical Wound Dehiscence
Bottom Line
View on ClinicalTrials.gov: NCT02581904 ↗Enrolled (actual)
140
Serious AEs
2.1%
Results posted
Feb 2026
Primary outcome: Primary: Groin Wound Complication — 6; 19; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prevena Care (Device); Dry gauze dressing care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Groin Wound Complication |
6; 19; 1 | — |
| SECONDARY Hospital Length of Stay |
10.6; 10.6; 3.8 | — |
| SECONDARY Return to Operating Room |
5; 11; 1 | — |
| SECONDARY Hospital Readmission |
4; 10; 1 | — |
| SECONDARY Index Hospital Cost |
29,2952; 30,678; 17,549 | — |
Summary
The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
Eligibility Criteria
Inclusion Criteria
- All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study
Exclusion Criteria
- Emergency procedure
- Unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT02581904). 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.