NCT07385313 · Aroa Biosurgery Limited
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
(COVER)
What this study is about
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
View original scientific description
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Aurora, Colorado
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations