The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb
Negative-Pressure Wound Therapy, Amputation, Wound Heal
About this trial
This is an interventional prevention trial for Negative-Pressure Wound Therapy focused on measuring Vascular disease, Diabetes, Preventive Care, Medical technology, Surgery
Eligibility Criteria
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
Sites / Locations
- Sygehus SoenderjyllandRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PICO VAC
Standard care
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 (sterile surgical silicone foam dressing and soft dressing)