AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 4Ages 18 Years - anyAllAroa Biosurgery Limited
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ350 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
๐Ÿ’Š

What it tests

  • Myriadโ„ข applied in conjunction with NPWT
  • NPWT Alone
๐Ÿ“

Where

2 sites
University of Colorado-Anschutz Medical Campus
Aurora, United States
The University of Texas Health Science Center at San Antonio
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy