Ovine forestomach matrix plus vacuum-assisted therapy to speed regeneration over exposed bone, tendon, or nerves

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 4 trial enrolls adults with full-thickness soft tissue defects (25–800 cm2) of the upper or lower extremity that expose bone, tendon, or neurovascular structures and compares standard negative pressure wound therapy (NPWT) alone versus NPWT combined with Myriad devices composed of decellularized ovine forestomach matrix (OFM). The Myriad devices, available as sheets (Matrix) or particulates (Morcells), are applied to the wound bed to support cellular infiltration, angiogenesis, and incorporation into host tissue while NPWT continues. The primary outcome focuses on time to tissue coverage of exposed structures and related wound-healing measures, with standardized wound care and follow-up at participating academic centers. The trial builds on preclinical and clinical data supporting OFM in soft tissue repair and aims to provide comparative evidence for traumatic wound management.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado-Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• The University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Julie Rizzo, MD — Brooke Army Medical Center
• Study coordinator: Lizette Villarreal, MA
• Email: Lizette@NatTrauma.org
• Phone: 2107182308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using thigh flaps to repair soft tissue injuries

  This study is testing a new surgical method using thigh skin to help people with serious soft tissue injuries heal better and look good afterwards.

  Recruiting Sohag University · Sohag · NCT06841419

• TrueLok Elevate transverse bone transport for lower‑limb ulcers

  This project tests the TrueLok Elevate device in adults with chronic lower‑limb ulcers to see if controlled bone cuts and gradual distraction improve local blood flow and help wounds heal.

  Recruiting at 5 sites Orthofix s.r.l. · Halle and 13 other locations · NCT07079774

• Buccal fat pad versus palatal rotation scarf graft for soft tissue around zygomatic implants

  We will test two grafting techniques—the buccal fat pad and the palatal rotation scarf—to see which better builds and stabilizes gum tissue around zygomatic implants in adults with severely atrophic upper jaws.

  Recruiting Cairo University · Cairo, Giza Governorate · NCT06968780

• 68Ga-HX01 PET/CT Imaging in Soft Tissue Sarcoma patients

  This study tests whether a 68Ga-HX01 injection can help PET/CT imaging better characterize soft tissue sarcoma in adults who have exhausted standard treatments or have no good options.

  Recruiting Phase 2 Hexin (Suzhou) Pharmaceutical Technology Co., Ltd · Wuhan, Hubei · NCT07920835

• Zemetostat plus Anlotinib for SWI/SNF-deficient Head and Neck Soft Tissue Sarcoma

  This trial tests whether zemetostat plus anlotinib can help people with recurrent or metastatic head-and-neck soft tissue sarcoma that has SWI/SNF complex deficiency after standard therapy fails.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07917949

• Entinostat for pediatric soft tissue sarcoma with PAX abnormalities

  This study tests entinostat, alone or with chemotherapy, in children whose soft tissue sarcomas have PAX-family gene abnormalities to see if it can help shrink tumors or slow progression.

  Recruiting Phase 1 Beijing Tongren Hospital · Beijing, Beijing Municipality · NCT07888114

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.