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The Use of a Platform Wound Device for Reducing Infection

NCT04753723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-10-14

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound, non-inferior to the current standard of care. This treatment will reduce or rapidly eradicate infection.

Conditions

  • Wounds and Injury
  • Burn Wound
  • Infection Wound

Interventions

COMBINATION_PRODUCT

Gentamycin with Platform Wound Device

Treatment of wounds with gentamycin and covered with platform wound device.

Sponsors & Collaborators

  • The Metis Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2021-11-19
Completion
2022-05-25
FDA Drug
Yes
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 NCT04753723 on ClinicalTrials.gov