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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Amputation, Negative-Pressure Wound Therapy, Wound Heal

Intervention / Treatment
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* Device: PICO VAC
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICO VAC<br>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. | Device: PICO VAC<br>* 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.<br>* Other names: PICO VAC (Smith and Nephew);|
| Active Comparator: Standard care<br>Standard care (sterile surgical silicone foam dressing and soft dressing) | Other: Standard care<br>* Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days<br>* Other names: Sterile surgical silicone foam dressing and soft dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of wound complications | Dehiscence (skin or fascia), seroma, lymph leak, infection (CDC surgical site infection criteria), Hematoma, Ischemia, Necrosis requiring any further local surgical treatment | Measured at 5 days and 2, 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants requiring re-surgery | Revision surgery | Within the first 6 weeks after surgery | 
| Number of participants requiring re-amputation | Re-amputation | Within the first 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular disease, Diabetes, Preventive Care, Medical technology, Surgery