Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty (PICO-PTC)

Civil Hospices of Lyon

Status: Completed

Conditions: Ankle Disease

Treatments: Device: Standard dressings; Device: PICO strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03886818

69HCL18_0753

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

PICO strategy

Experimental group

Description:

* Use of PICO™ device from the ankle surgery to the post-surgery day 7. * Use of usual care by simple dressings after post-surgery day 7 up to wound healing

Treatment:

Device: PICO strategy

Standard of care

Active Comparator group

Description:

-Usual care by simple dressings after the ankle surgery until the wound healing.

Treatment:

Device: Standard dressings