Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty
NCT ID: NCT03886818
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-03-25
2021-02-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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.
Standard of care
-Usual care by simple dressings after the ankle surgery until the wound healing.
Standard dressings
Standard dressings will be used from surgery to wound healing
Interventions
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Standard dressings
Standard dressings will be used from surgery to wound healing
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc Dr BESSE
Role: PRINCIPAL_INVESTIGATOR
Hospice Civils de Lyon
Locations
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Service de Chirurgie orthopédique - Groupement Hospitalier Lyon Sud
Lyon, , France
Countries
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Other Identifiers
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69HCL18_0753
Identifier Type: -
Identifier Source: org_study_id
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