The Activity of Tissue Engineering Skin Substitutes

Chinese PLA General Hospital20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Difficult to Heal Wounds

Interventions

liveness tissue skinBIOLOGICAL

liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds

Eligibility

Sex: ALLMin age: 17 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of Adverse Events

Frequency and severity of Adverse Events

Time frame: 6 months

Secondary Outcomes

Relative Wound Area Regression of 40% or More at 6 Week

Time frame: 6 week

Data from ClinicalTrials.gov

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