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

Not Applicable

Active, not recruiting

• Conditions: Wound Heal; Negative-Pressure Wound Therapy; Amputation
• Interventions: Device: PICO VAC; Other: Standard care

• Registration Number: NCT04618406
• Lead Sponsor: University of Southern Denmark

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Study Start: 2021-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICO VAC	PICO VAC	PICO14 device from Smith and Nephew. It is a Single-Use Negative Pressure Wound Therapy Device that provides an effective negative pressure of -80 mmHg for 14 days. It is an easily applied all-in-one system that ensures uniform application each time it is applied. The dressing consists of 4 distinct layers that reduce the risk of skin trauma, applies equal negative pressure to the skin and manages fluid transport away from the wound through a combination of absorption and evaporation through an airlock layer. The device is approved for the treatment of open wounds, closed surgical incisions and skin grafts. Both PICO-VAC and soft dressing are applied immediately postoperatively and removed after 12 days.
Standard care	Standard care	Standard care (sterile surgical silicone foam dressing and soft dressing)

Primary Outcome Measures

Name	Time	Method
Change in the number of wound complications	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 Outcome Measures

Name	Time	Method
Number of participants requiring re-surgery	Within the first 6 weeks after surgery	Revision surgery
Number of participants requiring re-amputation	Within the first 6 weeks after surgery	Re-amputation

Trial Locations

Locations (1)

Sygehus Soenderjylland; 🇩🇰 Aabenraa, Denmark