NCT04618406

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Negative-Pressure Wound Therapy
• Amputation
• Wound Heal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2020-11-05
• Last updated: 2025-03-18

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study