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

NCT02668055 | Completed Phase 1 DMC

• 1 other identifier: CHIN-PLAGH-ST-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wounds

Keywords

TB4; Difficult to heal

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

  Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing

  6 months

Secondary Outcomes (1)

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

  6week

Study Arms (1)

TB4

EXPERIMENTAL

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

Interventions

TB4 BIOLOGICAL

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

TB4

Eligibility Criteria

• Age: 17 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• xiaobing Fu

  Chinee PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

CN (1)