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Cultured Epithelial Autografts for massive burns patients

Evaluation of graft take rates in adults with burns exceeding 35% total body surface area receiving cultured epithelial autografts

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001342707
Enrollment
12
Registered
2013-12-09
Start date
2014-02-28
Completion date
2016-10-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this proof of concept study, we aim to demonstrate that CEA may be successfully produced from our laboratory and used in the clinical setting. With our strategy in the application of CEA sheets, we can match or better the quality of care previously provided by our unit, and other burn centres around the world.

Interventions

Autologous split skin grafts (SSG) remain the gold standard for management of patients with massive burns. However, autografts become insufficient to cover burn wounds when the total body surface area (TBSA) involved exceed thirty-five percent. The application of Cultured Epithelial Autograft (CEA) technology involves taking a skin sample from the burns patient, culturing and expanding the skin cells before re-applying the end product to cover the burn wounds in the same patient. The skin samp

Autologous split skin grafts (SSG) remain the gold standard for management of patients with massive burns. However, autografts become insufficient to cover burn wounds when the total body surface area (TBSA) involved exceed thirty-five percent. The application of Cultured Epithelial Autograft (CEA) technology involves taking a skin sample from the burns patient, culturing and expanding the skin cells before re-applying the end product to cover the burn wounds in the same patient. The skin sample consists of an elliptical full thickness skin biopsy (2x5cm) harvested from a hair-bearing area such as groin, axilla or scalp. In certain circumstances where it is not feasible to take a full thickness skin sample from the participant for processing (ie donor hair-bearing areas such as groin, axilla and scalp are involved in the burn injury), a 2x5cm split skin biopsy may be taken (with a dermatome) instead from an available and appropriate region. Harvesting of the skin sample is anticipated to take no longer than 10-20 minutes. The exact timing of CEA application depends on factors such as wound bed preparation and patient stability. However, CEA manufactured from our Skin Culture Laboratory is ready to be applied approximately 14 days after the initial skin biopsy. All the patients will receive autologous split skin grafts, the gold standard for management of patients with massive burns. Prepared wound beds are closed as much as possible with meshed autologous split skin grafts, in particular, difficult areas susceptible to shear forces and poor graft take (posterior trunk) or areas susceptible to joint contractures (joint flexures, hands). The exact quantity of CEA produced and used in any particular patient depends on the individual clinical requirements, rate of expansion and production capabilities of the clinical laboratory.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria include adult patients (18-70 years of age) with burns exceeding 35% TBSA admitted to the Victorian Adult Burns Service at The Alfred (tertiary referral burns centre).

Exclusion criteria

Patients less than 18 years of age or more than 70 years of age.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026