Two surgeons at work in an operating room

Acellular Allograft Amniotic Membrane in Keloid Revision

Keloids are one of the most stubborn problems in reconstructive surgery. Excision takes the lesion, but it leaves the same tissue environment that grew it, and recurrence after revision is common and hard to predict. Inconsistent outcomes are closer to the rule than the exception, which is why surgeons keep looking for something more to bring to the closure.

An acellular allograft amniotic membrane is one such option. Placed at the excision site as a protective covering, barrier, and structural scaffold, it is an intact extracellular matrix. Its representative makeup is precisely defined and verified lot-to-lot.

Tissue Characterization

Every lot is verified, not assumed. Acellularity is confirmed by DNA percent reduction and residual DNA quantification. The retained matrix is documented through immunohistochemical detection of critical basement membrane and extracellular matrix constituents, and histological assessment of tissue material organization and microarchitecture.

Protective Structural Scaffold Adjunct
Image of a keloid scar
Keloid Revision

Keloid and hypertrophic scars carry a weight beyond the skin. The itch and the pull are real, and so is the quiet wish, every morning, that it simply weren't there.

Each lot is tested against end-process acceptance criteria, including GLP biocompatibility and toxicity testing per ISO 10993 (pyrogenicity, cytotoxicity, genotoxicity, sensitization, irritation, systemic toxicity, endotoxicity, hemolysis), as well as shelf-life and packaging validation.

In Practice

Keloid revision is performed by plastic, reconstructive, and aesthetic surgeons, often as a cash-pay procedure. Common revision sites include incisional keloids along cesarean and breast surgery closures and excisions in high visibility areas. The allograft is placed at the excision site as a protective covering, barrier, and structural scaffold; applicability and use remain the judgment of the treating surgeon.

Summary

A rigorously characterized, acellular allograft amniotic membrane, a protective covering, barrier, and structural scaffold for the keloid revision site, room-temperature stable, and delivered directly. 

Start a Conversation

A: No. It is FDA-regulated, not FDA-approved. The tissue is an acellular allograft amniotic membrane, precision-cut as a single layer of amnion, regulated as a human tissue product under 21 CFR Part 1271 and Section 361 of the Public Health Service Act, and intended for homologous use.
A: Following excision, the allograft is placed at the surgical site as a protective covering, barrier, and structural scaffold, an intact extracellular matrix. Applicability and use remain the judgment of the treating surgeon.
A: Acellularity is confirmed by DNA percent reduction and residual DNA quantification. The retained matrix is documented by immunohistochemical detection of basement membrane and extracellular matrix constituents, and by histological assessment of tissue organization and microarchitecture. Every lot is verified, not assumed.
A: Amniotic membrane’s basic functions are to serve as a covering, a protective barrier, and a structural scaffold, the same structural roles it performs in its native state. It is an acellular extracellular matrix.
A: No. It is room-temperature stable, precision-cut as a disc or ellipse, packaged in a double pouch and terminally processed by low-dose gamma irradiation. There is no side-specific orientation to the graft.

TISSUE CHARACTERIZATION AND PROCESS VALIDATION DATA AVAILABLE TO QUALIFIED CLINICIANS UPON REQUEST