Recruiting

OFM vs. NPWTCombined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures

Sponsor:

Aroa Biosurgery Limited

Code:

NCT07385313

Conditions

Soft Tissue Defects

Soft Tissue Wounds

Traumatic Soft Tissue Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Myriad™ applied in conjunction with NPWT

NPWT Alone

Study Details

Brief 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

Study ID

NCT07385313

Start date

Mar 31, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients will be considered eligible for the study based on the following criteria:

Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan
Male or female patients aged 18 years or above
Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity.
Total defect size, range 25 to 800 cm2

Exclusion Criteria:

Patients will be excluded from the study based on the following criteria:

Patients with known sensitivity to ovine (sheep) derived material
Pregnant or lactating females.
Patients who are prisoners.
Patients who are likely not to complete the study.
Patients who, in the opinion of the Investigator, are unlikely to comply with the protocol.
Patients currently participating in or have participated in another clinical study within the past 30 days prior to enrolment that at the discretion of the Investigator makes them unsuitable for inclusion in the study.
Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.
Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study.
Obesity (BMI>45)
Blood glucose ≥350 mg/dL at admission
History of chronic peripheral vascular disease
Current immunosuppression
Recent neoadjuvant chemotherapy or radiotherapy
Previous or concurrent application of a cell/tissue-based product (CTP, or skin substitute) at the wound site within 30 days of the Screening Visit
Defect is a third degree burn

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Arm

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

active comparator: Control Arm

NPWT alone ('NPWT')

Interventions

Myriad™ applied in conjunction with NPWT

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

NPWT Alone

Control Arm: NPWT alone ('NPWT')

Primary outcome measure

Tissue Coverage [ Time Frame: Up to 56 days/ 8 week follow up ]

Central Contacts and Locations

Central contacts

Lizette Villarreal, MA

2107182308 Lizette@NatTrauma.org

Serina Zorilla, MSN

7039300041 serina@nattrauma.org

Locations

University of Colorado-Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alyssa Caldwell-McGee

303-517-2669 alyssa.caldwell-mcgee@cuanschutz.edu

Tracey MacDermott

(303)724-2757 TRACEY.MACDERMOTT@CUANSCHUTZ.EDU

Principal Investigator:

Michael Cripps, MD

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Stephanie DeMoor

210-743-4147 DeMoorS@uthscsa.edu

Rachelle Jonas

2107434144 babbittr@uthscsa.edu

Principal Investigator:

Susannah Nicholson, MD

More Information

Sponsor

Aroa Biosurgery Limited

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

Traumatic Wounds
Soft Tissue Repair
Negative Pressure Wound Therapy
Ovine Forestomach Matrix
Wound Healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aroa Biosurgery Limited on 2026-04-13.