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StrataGraft Skin Tissue Expanded Access at Specific Study Sites

2019-10-15 11:10:35 | BioPortfolio

Summary

Autograft is a procedure that uses skin from other parts of the body to treat bad burns.

This procedure is very painful.

StrataGraft is an experimental tissue to use instead of the person's own skin.

- The sponsor has already been running clinical trials

- The product seems to be effective and safe enough to be used

- Soon the sponsor will be applying for approval from FDA

The sponsor submitted a treatment protocol to FDA for experienced doctors to keep using StrataGraft before it is marketed (expanded access).

The main purpose of the study is to allow patients to keep receiving StrataGraft prior to approval. The primary outcome measure will be the number of participants with adverse events.

Description

The primary purpose of this trial is to provide expanded access to StrataGraft for thermally induced deep partial-thickness burns that contain intact dermal elements and for which surgical excision and autograft are clinically indicated.

Study Design

Conditions

Deep Partial-thickness Burn

Intervention

StrataGraft skin tissue

Location

University of South Alabama Medical Center
Mobile
Alabama
United States
36617

Status

Temporarily not available

Source

Stratatech, a Mallinckrodt Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:10:35-0400

Clinical Trials [2831 Associated Clinical Trials listed on BioPortfolio]

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the he...

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

The proposed study is designed as a phase II open-label, controlled, randomized, multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or multiple applic...

Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns

To assess the Safety and Tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary covera...

StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects

This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each wi...

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

The proposed registration study is designed as a phase III open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue in promoting ...

PubMed Articles [14246 Associated PubMed Articles listed on BioPortfolio]

Acellular Fish Skin Grafts for Management of Split Thickness Donor Sites and Partial Thickness Burns: A Case Series.

Ten patients having split-thickness skin grafting for burn injury were treated with the fish skin xenografts.

A Cultured Autologous Dermo-epidermal Skin Substitute for Full-Thickness Skin Defects: A Phase I, Open, Prospective Clinical Trial in Children.

The management of deep partial-thickness and full-thickness skin defects remains a significant challenge. Particularly with massive defects, the current standard treatment, split-thickness skin grafti...

A dual deformable liposomal ointment functionalized with retinoic acid and epidermal growth factor for enhanced burn wound healing therapy.

An ointment containing retinoic acid deformable liposomes (TRA DLs) and epidermal growth factor cationic deformable liposomes (EGF CDLs) was prepared for the treatment of deep partial-thickness burns....

Temporal shifts in the mycobiome structure and network architecture associated with a rat (Rattus norvegicus) deep partial-thickness cutaneous burn.

With a diverse physiological interface to colonize, mammalian skin is the first line of defense against pathogen invasion and harbors a consortium of microbes integral in maintenance of epithelial bar...

A new method for securing dermal substitutes and skin grafts to difficult portions of the face using a custom 3D-printed facemask.

Management of third-degree facial burns remains one of the most difficult challenges in burn care. Patients with deep facial burns usually require gradual escharectomy, tangential excision of the woun...

Medical and Biotech [MESH] Definitions

Layers of connective tissue of variable thickness. The superficial fascia is found immediately below the skin; the deep fascia invests MUSCLES, nerves, and other organs.

The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)

Specialized hospital facilities which provide intensive care for burn patients.

A prenatal ultrasonic measurement of the thickness or translucent area below the SKIN in the back of the fetal NECK, or nape of the neck, during the first 11-14 weeks of gestation (PREGNANCY TRIMESTER, FIRST). Abnormal thickness or nuchal translucent measurements resulting from fluid collection, is associated with increased risks of CHROMOSOME ABNORMALITIES. (Nicolaides et al., 1992)

An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions.

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