The Activity of Tissue Engineering Skin Substitutes

Difficult to Heal Wounds Clinical Trial

— MSCs  

Official title:

Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668042
• Other study ID #: CHIH-PLAGH-ST-006
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2016
• Last updated: January 28, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Difficult to Heal Wounds

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduced pain	Reduced pain, measured by VAS scale and use of analgesics	6 months after treatment	Yes
Primary	Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months	Yes
Secondary	Relative Wound Area Regression of 40% or More at 6 Week		6 week	Yes