Clinical trial NCT03886818: Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty
Official title: Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence.
timeFrame: Up to 12 months after TAA
Secondary outcomes:
measure: Rate of technical failures of the PICO™ device, and type of failure: device failure, non-hermetic dressing, other.
timeFrame: baseline to postoperative day 7
measure: Number and type of adverse effects related to the PICO™ device.
timeFrame: baseline to postoperative day 7
measure: Rate of wound healing complications: presence of exudate; blister; necrosis; wound dehiscence.
timeFrame: postoperative day 21, postoperative week 6, postoperative months 4 and 12.
measure: Rate of surgical site infection (superficial, deep or of a surgical site other than the incision site).
timeFrame: postoperative day 30 to postoperative month 12.
measure: Rate of surgical revision for wound healing complications defined by: mechanical debridement; surgical debridement; flap surgery and skin graft.
timeFrame: Baseline to postoperative month 12.
measure: Incremental Cost-Effectiveness Ratio (ICER) between the two dressing strategies.
timeFrame: Up to 12 months after TAA.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Chirurgie orthopédique - Groupement Hospitalier Lyon Sud
Study officials:
affiliation: Hospice Civils de Lyon
name: Jean-Luc Dr BESSE
role: PRINCIPAL_INVESTIGATOR
References: