The Activity of Tissue Engineering Skin Substitutes

Phase 1

Completed

• Conditions: Difficult to Heal Wounds
• Interventions: Biological: liveness tissue skin

• Registration Number: NCT02668042
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds

Detailed Description

This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Meet difficult had 1 month or more to heal the wound patients
2. Who signed the informed consent of men or women older than 17 (pregnancy)
3. Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
4. The process of mental stability, can finish the test

Exclusion Criteria

1. Known allergic to bovine collagen or gao min physique
2. the wound is greater than the10cm×10cm
3. People with mental illness, drug abusers and or other items
4. Pregnant women,Prepare a pregnancy or breast feeding women
5. 3 months participated in other similar experiment
6. Serious infectious disease not controller
7. With surgery, such as severe trauma stress situation
8. Can not meet the requirement of the long-term follow-up of patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
liveness tissue skin	liveness tissue skin	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	6 months	Frequency and severity of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Relative Wound Area Regression of 40% or More at 6 Week	6 week