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New treatment option for Soft Tissue Defects
Official title Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
ClinicalTrials.gov ID: NCT07385313
What this study is testing
- What it's testing
- Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Total defect size, range 25 to 800 cm2
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.