Cellular and Matrix-like Products for Bed Sores
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test new treatments for stubborn bed sores that resist healing. Researchers will compare standard treatments to two new options, ACApatch™ and caregraFT™, which use special tissue from the placenta to aid wound healing. Individuals with a severe bed sore on the trunk (such as the lower back or hip) for over a month, who have attempted to relieve pressure, might be suitable candidates. The goal is to determine if these new treatments can heal bed sores more effectively than current methods. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, providing an opportunity to assess its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressants, certain chemotherapy drugs, or medications that might interfere with wound healing.
What is the safety track record for ACApatch™ and caregraFT™?
Research has shown that ACApatch™ and caregraFT™, both derived from human placental tissue, have treated various ulcers, such as diabetic foot ulcers and venous leg ulcers. These ulcers are similar to pressure ulcers, which this study targets. Patients typically tolerate both products well.
Patients using similar skin substitutes in the past have experienced few side effects, indicating these treatments are generally safe. As this trial is in a later phase, earlier trials have already provided some safety information. However, individual reactions can vary. Participants should discuss any concerns with the trial coordinators or their doctors.12345Why are researchers enthusiastic about this study's treatments?
Researchers are excited about ACApatch™ and caregraFT™ for treating bed sores because they utilize human amniotic membrane tissue allografts derived from placental tissue. This is a unique approach compared to the standard care, which relies on cleaning, debridement, and maintaining moisture balance. These allografts are believed to promote healing by providing a natural scaffold that supports cell growth and tissue regeneration. This innovative method could potentially speed up recovery and improve outcomes for patients suffering from bed sores, making it a promising alternative to traditional treatments.
What evidence suggests that this trial's treatments could be effective for bed sores?
Research has shown that ACApatch™, which uses a special four-layer tissue from the placenta, could enhance standard treatments for hard-to-heal wounds like pressure ulcers. This tissue supports the body's natural healing. In this trial, some participants will receive ACApatch™ alongside standard care.
Meanwhile, studies have found that amniotic membrane tissues, like those in caregraFT™, promote wound healing by encouraging new skin growth. Specifically, frozen amniotic membrane has proven effective as a dressing for pressure ulcers, aiding in skin repair. Other participants in this trial will receive caregraFT™ in combination with standard care. The trial aims to evaluate how well both products help heal bed sores when used with regular treatments.56789Who Is on the Research Team?
Thomas Serena, MD
Principal Investigator
Serena Group
Are You a Good Fit for This Trial?
This trial is for individuals with nonhealing pressure ulcers, commonly known as bed sores. Participants should meet specific criteria to join the study, but those details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either CAMPs plus SOC or matched SOC controls for the management of nonhealing pressure ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACApatch™
- caregraFT™
Trial Overview
The study is testing the effectiveness of different products called CAMPs (caregraFT™ and ACApatch™) combined with standard wound care against just the usual wound care alone in treating nonhealing pressure ulcers.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Human amniotic membrane tissue allografts derived from human placental tissue.
Human amniotic membrane tissue allografts derived from human placental tissue.
Standard of care will be cleaning, debridement, and ulcer moisture balance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tiger Biosciences, LLC.
Lead Sponsor
ExtremityCare, LLC.
Collaborator
SerenaGroup, Inc.
Collaborator
Citations
1.
internationaljournaloftissuerepair.com
internationaljournaloftissuerepair.com/index.php/ijtr/article/view/16/21Application of an amnion chorion amnion (ACA) four-layer ...
Conclusions: Results suggest that four-layer placental allografts may be promising adjuncts to SOC for the management of complex wounds like ...
Improving Outcomes by Implementing a Pressure Ulcer ...
Mallah et al. also recommends repositioning the bed-ridden patient every two hours to help eliminate interface pressure ulcer development [15].
Skin Substitute Grafts/Cellular and Tissue-Based Products ...
It was noted that studies seldom reported clinical outcomes, such as amputation, ulcer recurrence at least 2 weeks after treatment ended, or patient-related ...
4.
univerahealthcare.com
univerahealthcare.com/documents/d/global/uni-prv-bioengineered-tissue-products-for-wound-treatment-and-surgical-interventionsBioengineered Tissue Products for Wound Treatment and ...
The purpose of this study is to report intention-to-treat (ITT) results on all 128 randomized subjects and assess if both ITT and per-protocol ( ...
5.
ldh.la.gov
ldh.la.gov/assets/medicaid/MCPP/8.6.24/222_UHC_skin_soft_tissue_substitutes_cs1_la_Redline-V2.pdfSkin and Soft Tissue Substitutes (for Louisiana Only)
The authors concluded that although the dehydrated amniotic membrane provided significant clinical relief at 0-2 months, there were no data about this treatment ...
Pressure Ulcers: A Patient Safety Issue - NCBI - NIH
When air is pumped through the bed, the beads become liquid. These beds are used for patients at very high risk for pressure ulcers. More often they are ...
Preventing Pressure Ulcers in Hospitals
The aim of this toolkit is to assist hospital staff in implementing effective pressure ulcer prevention practices through an interdisciplinary approach to care.
8.
excellusbcbs.com
excellusbcbs.com/documents/d/global/exc-prv-bioengineered-tissue-products-for-wound-treatment-and-surgical-interventionsMedical Policy - Bioengineered Tissue Products for Wound ...
After study inclusion criteria, data were included on the treatment of 226 diabetic foot ulcers from 99 wound care centers. Foot wounds were ...
9.
uhcprovider.com
uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/skin-soft-tissue-substitutes-08012025.pdfSkin and Soft Tissue Substitutes
The pilot trial does not report outcomes for wound types separately (i.e., venous leg ulcers, DFUs, pressure ulcers, arterial ulcers, and ...
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