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OpenTrials
Completed

NCT Number: NCT02486874

Clinical Evaluation of PoreSkin

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.

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Key information

Conditions

Treatment Burns Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PoreSkin

Device

a human acellular dermal matrix

Primary outcomes

  1. The engraftment rate

    Time frame: 1 month

Secondary outcomes

  1. Any local complications

    Time frame: 1 month

    erythema, infection, fever, and rejection of the graft

  2. the final cosmetic result

    Time frame: 1 month

    evaluated by Vancouver Scar scale

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2015
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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