Phase 4
Completed N=140
A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications
Source: ClinicalTrials.gov NCT02581904 ↗Enrolled (actual)
140
Serious AEs
2.1%
Results posted
Feb 2026
Primary outcomePrimary: Groin Wound Complication — 6; 19; 1 Participants
◆ Published Evidence
Established
96citations · ~12 / year
A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.
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.
Linked Publications (3)
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A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.
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Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction.
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Prevention of infection in peripheral arterial reconstruction of the lower limb.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.