UnknownNot Applicable

RCT on NPWT for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection

290 participantsStarted 2018-03

Plain-language summary

Surgical site infections following lower extremity amputations have been reported in up to 40% of patients. Surgical site infections have significant morbidity and even mortality in terms of emergency room visits, length of hospital stay, reamputation rates and death. Since its introduction, negative pressure wound therapy has been demonstrated to promote wound healing and possibly decreasing the need for future amputations. The aim of the study is to provide level I evidence for the use of negative pressure wound therapy devices in patients undergoing lower extremity amputation.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * any patient 18 years or older undergoing amputation of the lower limb, either an above knee amputation (AKA) or below knee amputation (BKA) * ability to read and write English to undergo informed consent Exclusion Criteria: * patients in which a complete seal cannot be obtained at the time of vacuum placement * wounds that are not closed primarily * existing infection * patient is anticipated to not follow-up * inability to read and write English

What they're measuring

Surgical site infection

Timeframe: 30 days

Trial details

NCT IDNCT03144726

SponsorLondon Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

Contact for this trial

Oonagh Scallan, MD

6478761954 oonagh.scallan@lhsc.on.ca

View on ClinicalTrials.gov More Amputation Wound trials