The Activity of Tissue Engineering Skin Substitutes | NCT02668042

Studies
The Activity of Tissue Engineering Skin Substitutes

NCT02668042

Sponsor

Chinese PLA General Hospital

Status

Completed

Last Update Posted

Jan 29, 2016Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Difficult to Heal Wounds

Interventions

liveness tissue skin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 21, 2016

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Jan 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2016

Last Update Posted Date

Jan 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liveness tissue skin	Experimental		Biological: liveness tissue skin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liveness tissue skin	Biological	liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds	liveness tissue skin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months

Secondary Outcomes

Measure	Description	Time Frame
Relative Wound Area Regression of 40% or More at 6 Week		6 week

Other Outcomes

Measure	Description	Time Frame
Reduced pain	Reduced pain, measured by VAS scale and use of analgesics	6 months after treatment

Eligibility Module

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
3 months participated in other similar experiment
Serious infectious disease not controller
With surgery, such as severe trauma stress situation
Can not meet the requirement of the long-term follow-up of patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
xiaobing Fu	Chinese PLA General Hospital	Principal Investigator

Locations

Not provided