Amputation, Negative-Pressure Wound Therapy, Wound Heal
Conditions
Keywords
Vascular disease, Diabetes, Preventive Care, Medical technology, Surgery
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.
Interventions
DEVICEPICO 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.
OTHERStandard care
Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORLars Grau Lykkeberg, MD
Hospital Sonderjylland
Outcome results
None listed