PICO- Single-use Negative Pressure Wound Therapy System
NCT ID: NCT05064696
Last Updated: 2023-09-21
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-08-25
2025-09-30
Brief Summary
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Detailed Description
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The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1 (Control group)
Surgical wound will be covered with the standard non-stick gauze dressing.
Non-stick gauze dressing
Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
Group 2 (Treatment group)
Surgical wound will be covered with the PICO dressing.
PICO dressing
Group 2 (Treatment group): surgical site will be dressed with PICO dressing
Interventions
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Non-stick gauze dressing
Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
PICO dressing
Group 2 (Treatment group): surgical site will be dressed with PICO dressing
Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
* Subjects able to provide informed consent
* Subjects who are able to understand and comply with study visit schedule and procedures
Exclusion Criteria
* Allergy to products used in the study
* Pregnant and breastfeeding women due to anesthesia risks
* Subjects with a known history of poor compliance with medical treatment
* Subjects who decline participation in this research study
* Prisoners
18 Years
ALL
Yes
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Walter C Hembree
OTHER
Responsible Party
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Walter C Hembree
MD
Principal Investigators
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Walter C Hembree, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Health
Locations
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Amy Loveland
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00003790
Identifier Type: -
Identifier Source: org_study_id
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