PICO- Single-use Negative Pressure Wound Therapy System

NCT05064696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-09-21

No results posted yet for this study

Summary

To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Conditions

  • Total Ankle Arthroplasty

Interventions

OTHER

Non-stick gauze dressing

Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing

DEVICE

PICO dressing

Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY
  • Walter C Hembree

    lead OTHER

Principal Investigators

  • Walter C Hembree, MD · MedStar Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2024-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064696 on ClinicalTrials.gov