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

Wounds Clinical Trial

— TB4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668055
• Other study ID #: CHIN-PLAGH-ST-005
• Status: Completed
• Phase: Phase 1
• First received: January 20, 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

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.

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 78 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

• Wounds

Intervention

Biological:
• TB4
Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events	Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing	6 months	Yes
Secondary	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	Yes