OFM + Negative Pressure Wound Therapy for Wounds
(COVER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new wound treatment by combining two therapies: OFM, a special material, and negative pressure wound therapy, which acts like a vacuum. The goal is to determine if this combination speeds up healing, particularly for wounds exposing bones or tendons. Individuals with full-thickness wounds on their arms or legs, measuring between 25 and 800 square centimeters, may qualify. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What is the safety track record for the combined OFM and vacuum-assisted therapy?
Research has shown that using OFM with negative pressure wound therapy (NPWT) is generally safe. Patients who used this combination found it well-tolerated, and earlier studies reported no major safety issues.
Studies have also confirmed that NPWT alone is a safe option. Compared to standard dressing methods, it has proven to be a reliable way to treat wounds.
In summary, both the combined OFM and NPWT therapy and NPWT alone have demonstrated safety based on past research.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the combination of OFM (Oxygenated Foam Matrix) and Negative Pressure Wound Therapy (NPWT) because it offers a novel approach to wound healing. Unlike standard treatments that typically rely on NPWT alone to create a vacuum environment for enhanced healing, the addition of OFM provides a unique delivery of oxygen directly to the wound site. This dual action not only helps maintain a clean environment but also promotes faster tissue regeneration. By combining these two methods, the treatment is expected to accelerate healing times and improve outcomes for patients with challenging wounds.
What evidence suggests that this trial's treatments could be effective for wounds?
Research shows that using OFM, a special wound treatment, with negative pressure wound therapy (NPWT) can accelerate wound healing. One study found that diabetic foot ulcers healed about 5.5 weeks faster with OFM than with other treatments. Another study discovered that combining NPWT with therapies like light therapy also sped up healing. This trial will compare the combination of OFM and NPWT, received by participants in the interventional arm, with NPWT alone, received by participants in the control arm. This suggests that using OFM with NPWT could improve healing times for wounds. This treatment is already approved for other uses, demonstrating its effectiveness in aiding wound healing.16789
Who Is on the Research Team?
Julie Rizzo, MD
Principal Investigator
Brooke Army Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with full thickness soft tissue wounds between 25 to 800 cm2, exposing bone, tendon, or neurovascular structures in limbs. Participants must consent and follow the study plan.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Myriad devices in conjunction with NPWT or NPWT alone for traumatic wound management
Follow-up
Participants are monitored for safety and effectiveness after treatment, including tissue coverage and post-operative complications
What Are the Treatments Tested in This Trial?
Interventions
- Combined OFM and Vacuum-assisted Therapy
Trial Overview
The trial tests if using Myriad™ (an OFM) with NPWT speeds up tissue coverage over exposed structures compared to just NPWT alone. It's a head-to-head comparison of these two wound treatment methods.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
NPWT alone ('NPWT')
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aroa Biosurgery Limited
Lead Sponsor
Coalition for National Trauma Research
Collaborator
Citations
OFM + Negative Pressure Wound Therapy for ...
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone. Show more ...
Efficacy of negative pressure wound therapy using vacuum ...
Both VAC and VAC combined with photon therapy were effective and safe in the treatment of DFUs, while the combined therapy might have accelerated wound healing.
Influence of advanced wound matrices on observed ...
A recent real world evidence study of over 2200 diabetic foot ulcers demonstrated that wounds closed up to ∼5.5 weeks faster when treated with OFM versus a ...
4.
researchgate.net
researchgate.net/publication/366379333_Influence_of_advanced_wound_matrices_on_observed_vacuum_pressure_during_simulated_negative_pressure_wound_therapy(PDF) Influence of advanced wound matrices on observed ...
This study evaluated the impact of the design and composition of commercially available collagen-based matrices on the observed vacuum pressure ...
Review Article A systematic review and meta-analysis of ...
To systematically review and compare the efficacy of s-HBOT, PRP therapy, VAC Therapy, and NPWT in the treatment of diabetic foot ulcers. 2. To ...
6.
tipranks.com
tipranks.com/news/company-announcements/aroa-biosurgery-targets-trauma-wound-market-with-new-phase-4-myriad-npwt-trialAroa Biosurgery Targets Trauma Wound Market With New ...
The trial compares two treatments. The interventional arm uses Myriad, an OFM-based wound device from Aroa, together with negative pressure ...
The Efficacy and Safety of Negative‐Pressure Wound Therapy ...
This study demonstrates that the combination of negative‐pressure wound therapy and platelet‐rich plasma can improve the efficacy and safety on chronic ...
Myriad™ applied in conjunction with NPWT and ... - ICH GCP
The following study has been designed as a randomized clinical investigation to demonstrate the safety and efficacy of Myriad devices in ...
Negative Pressure Wound Therapy for the Treatment ...
This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens in Ontario and the results will serve as a benchmark for the ...
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