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

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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Disease
• Intervention / Treatment: Device: PICO strategy; Device: Standard dressings

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69310
    • Service de Chirurgie orthopédique - Groupement Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO strategy; 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; 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.
Active Comparator: Standard of care; -Usual care by simple dressings after the ankle surgery until the wound healing.	Device: Standard dressings; Standard dressings will be used from surgery to wound healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-Luc Dr BESSE, Hospice civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): February 17, 2021
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No