Difficult to Heal Wounds
Conditions
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.
Interventions
BIOLOGICALliveness tissue skin
liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 6 months | Frequency and severity of Adverse Events |
Secondary
| Measure | Time frame |
|---|---|
| Relative Wound Area Regression of 40% or More at 6 Week | 6 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduced pain | 6 months after treatment | Reduced pain, measured by VAS scale and use of analgesics |
Outcome results
None listed