Clinical Evaluation of PoreSkin

Chulalongkorn University

Status and phase: Completed; Phase 1

Conditions: Treatment

Treatments: Device: PoreSkin

Study type: Interventional

Funder types: Other

Identifiers

NCT02486874

283/52

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Treatment group

Experimental group

Description:

PoreSkin, a human acellular dermal matrix, were used for scar contracture treatment

Treatment:

Device: PoreSkin