Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds

Study Overview
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Brief Summary
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Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.

Official Title
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Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies

Conditions
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Wounds

Intervention / Treatment
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* Biological: TB4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet difficult had 1 month or more to heal the wound patients Who signed the informed consent of men or women older than 17 (pregnancy) 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 The process of mental stability, can finish the test Exclusion Criteria: Known allergic to bovine collagen or gao min physique the wound is greater than the10cm×10cm People with mental illness, drug abusers and or other items 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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TB4<br>Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells in wound, stick with wound edge skin suture, with vaseline gauze bandaging, controlled side not adding slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes | Biological: TB4<br>* Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events | Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Wound Area Regression of 40% of More at 6 Week | Subsistence the wound tissue(4 mm ×4 mm) biopsy samples, to determine the wound repair | 6week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TB4, Difficult to heal