NCT02486874

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

June 3, 2015

Last Update Submit

June 29, 2015

Conditions

Treatment

Keywords

Human acellular dermal matrix, burns, wound healing

Outcome Measures

Primary Outcomes (1)

  • The engraftment rate

    1 month

Secondary Outcomes (2)

  • Any local complications

    1 month

  • the final cosmetic result

    1 month

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Device: PoreSkin

Interventions

PoreSkinDEVICE

a human acellular dermal matrix

Treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients
  • years with burn scar contracture and hypertrophic scar

You may not qualify if:

  • Undergoing immunosuppressive therapy
  • Immunocompromise host (DM, HIV infected)
  • Evidence of malnutrition
  • Active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Apichai Angspatt

Study Record Dates

First Submitted

June 3, 2015

First Posted

July 1, 2015

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 1, 2015

Record last verified: 2015-05