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ACTIVE NOT RECRUITING
NCT04618406
NA

The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

Sponsor: University of Southern Denmark

View on ClinicalTrials.gov

Summary

The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a positive and measurable effect on wound healing following eg. total Knee and hip replacements. The aim of this study is to evaluate the effect of a closed NPWT on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.

Official title: The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2021-11-01

Completion Date

2025-07

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DEVICE

PICO VAC

PICO14 device from Smith and Nephew - Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager-sized) suction device/canister and provides a negative pressure of -80 mmHg for 14 days.

OTHER

Standard care

Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days

Locations (1)

Sygehus Soenderjylland

Aabenraa, Denmark