Clinical Evaluation of PoreSkin

NCT ID: NCT02486874

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

PoreSkin

Intervention Type DEVICE

a human acellular dermal matrix

Interventions

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PoreSkin

a human acellular dermal matrix

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Apichai Angspatt

Apichai Angspatt

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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283/52

Identifier Type: -

Identifier Source: org_study_id

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