Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty

  • STATUS
    Recruiting
  • End date
    Mar 25, 2022
  • participants needed
    48
  • sponsor
    Hospices Civils de Lyon
Updated on 4 July 2021

Summary

About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.

Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.

Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO (Smith&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.

To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.

Details
Condition Ankle Disease
Treatment Standard dressings, PICO strategy
Clinical Study IdentifierNCT03886818
SponsorHospices Civils de Lyon
Last Modified on4 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient aged 18 years or older
Patient for whom a total ankle arthroplasty has been scheduled
Patient affiliated to a national health insurance scheme or similar
Patient who have signed an informed consent form for its participation in the study

Exclusion Criteria

Patient with contraindication to use of the PICO device
Patient participating in another study including an exclusion period in progress
Patient participating in another interventional study that may interfere with this research
Adult patient protected by law, under guardianship or tutorship
Pregnant or breastfeeding women
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