Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures

NCT07385313 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

Summary

Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone

Conditions

  • Soft Tissue Defects
  • Soft Tissue Wounds
  • Traumatic Soft Tissue Defect

Interventions

DEVICE

Myriad™ applied in conjunction with NPWT

Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')

DEVICE

NPWT Alone

Control Arm: NPWT alone ('NPWT')

Sponsors & Collaborators

  • Coalition for National Trauma Research

    collaborator OTHER
  • Aroa Biosurgery Limited

    lead INDUSTRY

Principal Investigators

  • Julie Rizzo, MD · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-03-31
Completion
2027-04-30
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 NCT07385313 on ClinicalTrials.gov