Clinical Evaluation of PoreSkin

Phase 1

Completed

• Conditions: Treatment
• Interventions: Device: PoreSkin

• Registration Number: NCT02486874
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-05
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	PoreSkin	PoreSkin, a human acellular dermal matrix, were used for scar contracture treatment

Primary Outcome Measures

Name	Time	Method
The engraftment rate	1 month

Secondary Outcome Measures

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