Back to resultsSlow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds (TB4)
Primary Purpose
Wounds
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TB4
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring TB4, Difficult to heal
Eligibility Criteria
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
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TB4
Arm Description
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
Outcomes
Primary Outcome Measures
Frequency of Adverse Events
Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02668055
First Posted
January 20, 2016
Last Updated
January 28, 2016
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02668055
Brief Title
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
TB4, Difficult to heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TB4
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
TB4
Intervention Description
Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface
Primary Outcome Measure Information:
Title
Frequency of Adverse Events
Description
Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Relative Wound Area Regression of 40% of More at 6 Week
Description
Subsistence the wound tissue(4 mm ×4 mm) biopsy samples, to determine the wound repair
Time Frame
6week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaobing Fu
Organizational Affiliation
Chinee PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
12. IPD Sharing Statement
Learn more about this trial
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds
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