Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.

Conditions
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Ankle Disease

Intervention / Treatment
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* Device: Standard dressings
* Device: PICO strategy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICO strategy<br>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 | Device: PICO strategy<br>* The PICO system with negatif pression will be used from surgery to day 7. After that, standard dressing will be used untill the wound Healing.<br>|
| Active Comparator: Standard of care<br>-Usual care by simple dressings after the ankle surgery until the wound healing. | Device: Standard dressings<br>* Standard dressings will be used from surgery to wound healing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Up to 12 months after TAA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of technical failures of the PICO™ device, and type of failure: device failure, non-hermetic dressing, other. |  | baseline to postoperative day 7 | 
| Number and type of adverse effects related to the PICO™ device. |  | baseline to postoperative day 7 | 
| Rate of wound healing complications: presence of exudate; blister; necrosis; wound dehiscence. |  | postoperative day 21, postoperative week 6, postoperative months 4 and 12. | 
| Rate of surgical site infection (superficial, deep or of a surgical site other than the incision site). |  | postoperative day 30 to postoperative month 12. | 
| Rate of surgical revision for wound healing complications defined by: mechanical debridement; surgical debridement; flap surgery and skin graft. |  | Baseline to postoperative month 12. | 
| Incremental Cost-Effectiveness Ratio (ICER) between the two dressing strategies. | A cost-effectiveness analysis comparing the strategy using PICO device and the one using only conventional dressing will be performed during 12 months after surgery, from the perspectives of the French hospital and French health insurance system; the result will be expressed in terms of cost per complication avoided. | Up to 12 months after TAA. |