Clinical Evaluation of PoreSkin

Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02486874

Enrollment

Registered

2015-07-01

Start date

2009-09-30

Completion date

2010-07-31

Last updated

2015-07-01

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

Conditions

Treatment

Keywords

Human acellular dermal matrix, burns, wound healing

Brief summary

PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.

Interventions

DEVICEPoreSkin

a human acellular dermal matrix

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male and female patients * 18-60 years with burn scar contracture and hypertrophic scar

Exclusion criteria

* Undergoing immunosuppressive therapy * Immunocompromise host (DM, HIV infected) * Evidence of malnutrition * Active malignancy

Design outcomes

Primary

Measure	Time frame
The engraftment rate	1 month

Secondary

Measure	Time frame	Description
Any local complications	1 month	erythema, infection, fever, and rejection of the graft
the final cosmetic result	1 month	evaluated by Vancouver Scar scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026