Clinical Evaluation of PoreSkin

Chulalongkorn University11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Treatment

Interventions

PoreSkinDEVICE

a human acellular dermal matrix

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The engraftment rate

Time frame: 1 month

Secondary Outcomes

Any local complications

erythema, infection, fever, and rejection of the graft

Time frame: 1 month

the final cosmetic result

evaluated by Vancouver Scar scale

Time frame: 1 month

Data from ClinicalTrials.gov

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