Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:38 AM
Study NCT ID:
NCT07375160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
Sponsor:
Cellution Biologics
Organization:
Study Overview
Official Title:
A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRO-PLAST
Brief Summary:
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.
Detailed Description:
Around 10.5 million Medicare beneficiaries were affected by chronic wounds in 2019. A chronic wound is generally defined as any wound that fails to heal within a reasonable timeframe. Chronic wounds can be categorized into the following four groups: arterial, pressure, diabetic, and venous. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, and maintaining proper moisture balance, a notable gap remains between historical outcomes and desired results in chronic wound care.
One approach to treating chronic wounds involves the use of dehydrated human placental tissues, which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of dHTPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of dHTPs includes allografts, which are human donor tissue samples intended for use in another human patient. Utilizing human amniotic membrane as an allograft displays considerable promise for chronic wound treatment.
One approach to treating chronic wounds involves the use of dehydrated human placental tissues, which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of dHTPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of dHTPs includes allografts, which are human donor tissue samples intended for use in another human patient. Utilizing human amniotic membrane as an allograft displays considerable promise for chronic wound treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: