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

NCT04618406 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Negative-Pressure Wound Therapy
  • Amputation
  • Wound Heal

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

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Lars Grau Lykkeberg, MD · Hospital Sonderjylland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-06-30
Completion
2025-07-31
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618406 on ClinicalTrials.gov