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

NCT03144726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2017-12-08

No results posted yet for this study

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.

Conditions

  • Amputation Wound
  • Amputation Stump Complication
  • Amputation Stump; Infection
  • Infection

Interventions

DEVICE

Negative pressure wound therapy

Negative pressure wound therapy is a commonly utilized tool in the hospital setting and will be applied to amputations in our study to determine the effect on surgical site infections

OTHER

Standard dressing

A standard dressing will be applied to the amputations in this arm of the study

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Adam Power, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2019-07-31
Completion
2020-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144726 on ClinicalTrials.gov