N/A
N=272
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Amputation · Amputation; Postoperative, Sequelae · Wound Dehiscence · Seroma · Wound Infection, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT03773575 ↗Enrolled (actual)
272
Serious AEs
9.5%
Results posted
Feb 2026
Primary outcome: Primary: Overall Rate of Wound Complications — 26; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PREVENA™ PEEL & PLACE™ Dressing Kit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Rate of Wound Complications |
26; 31 | — |
| SECONDARY Length of Stay (LOS) |
10; 9.6 | — |
| SECONDARY 30-day Return to Operating Room (ROR) |
5; 11 | — |
| SECONDARY 30-day Hospital Readmissions |
12; 15 | — |
| SECONDARY Incidence of Skin Dehiscence |
15; 11 | — |
| SECONDARY Incidence of Fascial Dehiscence |
2; 2 | — |
| SECONDARY Incidence of Superficial Skin Infection |
2; 2 | — |
| SECONDARY Incidence of Deep Skin Infection |
5; 4 | — |
| SECONDARY Incidence of Seroma |
1; 1 | — |
| SECONDARY Incidence of Hematoma |
2; 3 | — |
| SECONDARY Incidence of Necrosis |
4; 10 | — |
Summary
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.
Eligibility Criteria
Inclusion Criteria
- Male or female adults 18 years or older
- Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
- Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
- Informed Consent signed by patient
Exclusion Criteria
- Minors under 18 years
- Women who are pregnant or breastfeeding
- Patients having BOTH legs amputated
- Patients with sensitivity to silver
- Unwilling or unable to provide informed consent
- Inability to comply with planned study procedures
Data sourced from ClinicalTrials.gov (NCT03773575). 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.