Sygehus Soenderjylland
Aabenraa, 6200, Denmark
NCT Number: NCT04618406
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Aabenraa, 6200, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: PICO VAC (Smith and Nephew)
Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days
Other names: Sterile surgical silicone foam dressing and soft dressing
Time frame: 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
Time frame: Within the first 6 weeks after surgery
Revision surgery
Time frame: Within the first 6 weeks after surgery
Re-amputation
University of Southern Denmark
Other
The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07258134
Infections, Negative-Pressure Wound Therapy
Karachi, Sindh, Pakistan
View Trial DetailsNCT02682316
Negative-Pressure Wound Therapy
Hartford, Connecticut, United States
View Trial DetailsNCT02526342
Edema, Free Flap
Munich, Germany
View Trial DetailsNCT07040683
Bandages, Infections
Malmö, Sweden
View Trial Details