The Activity of Tissue Engineering Skin Substitutes (MSCs)

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 1

Conditions: Difficult to Heal Wounds

Treatments: Biological: liveness tissue skin

Study type: Interventional

Funder types: Other

Identifiers

NCT02668042

CHIH-PLAGH-ST-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

liveness tissue skin

Experimental group

Treatment:

Biological: liveness tissue skin