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NCT02486874 Clinical Trial

Clinical Evaluation of PoreSkin

Treatment Clinical Trial

Official title:
Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02486874
Other study ID # 283/52
Secondary ID
Status Completed
Phase Phase 1
First received June 3, 2015
Last updated June 29, 2015
Start date September 2009
Est. completion date July 2010

Study information
Verified date May 2015
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• PoreSkin
a human acellular dermal matrix

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Outcome
Type Measure Description Time frame Safety issue
Primary The engraftment rate 1 month No
Secondary Any local complications erythema, infection, fever, and rejection of the graft 1 month Yes
Secondary the final cosmetic result evaluated by Vancouver Scar scale 1 month No
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