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Completed

NCT Number: NCT04618406

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

About this study

Historically lower limb amputations have been performed to treat infection or trauma, usually in the setting of war. Today however major amputations of the lower extremities (transfemoral- (TFA), knee disarticulations (KD) and transtibial amputations (TTA)) are, in developed countries, usually performed in elderly patients with untreatable vascular disease, diabetes or a combination of both. This fragile group of patients are characterized by a high degree of comorbidity, mortality and both surgical and postoperative complications; included herein problems with wound healing. The tissue is typically poorly vascularized and prone to wound break-down, infections, necrosis etc. 10-40% of patients undergoing TFA, KD or TTA have delayed wound healing and/or insufficient wound healing, resulting in problems with the aftercare, mobilization with a prosthesis and re-amputations. Recent retrospective studies show that Negative Pressure Wound Therapy (NPWT) may have beneficial effects on incisional healing following lower limb amputations. However to our knowledge it has never been reproduced in a prospective randomized controlled setting.The aim of this study is to investigate the effect of NPWT with a PICO®️ device (Smith & Nephew) on the healing of the surgical wound following TFA, KD and TTA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing transfemoral, knee disarticulations and transtibial amputations by non-traumatic indication
  • Uni or bilateral amputations or re-amputations

Exclusion criteria

  • Patients undergoing traumatic amputations
  • Unwilling or unable to provide informed consent
  • Inability to comply with planned study procedures
  • Amputations due to malignancy

Treatment and study plan

PICO VAC

Device

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 names: PICO VAC (Smith and Nephew)

Standard care

Other

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

Other names: Sterile surgical silicone foam dressing and soft dressing

Primary outcomes

  1. Change in the number of wound complications

    Time frame: Measured at 5 days and 2, 3 and 6 weeks

    Dehiscence (skin or fascia), seroma, lymph leak, infection (CDC surgical site infection criteria), Hematoma, Ischemia, Necrosis requiring any further local surgical treatment

Secondary outcomes

  1. Number of participants requiring re-surgery

    Time frame: Within the first 6 weeks after surgery

    Revision surgery

  2. Number of participants requiring re-amputation

    Time frame: Within the first 6 weeks after surgery

    Re-amputation

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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