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Rapid Construction of Tissue-engineered Skin for Repairing Wounds

Primary Purpose

Wound

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tissue-engineered skin method
split-thickness skin graft method
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound focused on measuring wound, tissue-engineered skin

Eligibility Criteria

undefined - 81 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who need to skin graft to repair the wound
  • Subjects signed the informed consent in the day of the age of not more than 81 years old (for minors, legal guardian should be signed)
  • Stable vital signs, regular examination showed that subjects could tolerate surgery
  • Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis
  • Understanding and willing to participate in this clinical trial and signed informed consent
  • All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment
  • No other serious diseases conflicts with the trail
  • Wound size between 3 cm2 and 100 cm2, no limited to location

Exclusion Criteria:

  • Allergic constitution of enzyme
  • Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease
  • Subjects with mental illness
  • Subjects could not cooperate with the clinical trial personnel to finish trials
  • Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound
  • For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely < 1000 cells/mm3
  • Subjects could not tolerate surgery
  • Subjects are unlikely to survive in the study period
  • The investigators think that who should not be included
  • Subjects are in or participated in other clinical researchers over the past 12 weeks
  • Subjects are participated in this trial at any time in the past

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tissue-engineered skin method

split-thickness skin graft method

Arm Description

This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells

This method is traditional split-thickness skin graft

Outcomes

Primary Outcome Measures

healing rate
the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements.

Secondary Outcome Measures

wound reducing rate
the rate of wound reducing based on week 4 after surgery

Full Information

First Posted
February 22, 2014
Last Updated
February 13, 2019
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02070809
Brief Title
Rapid Construction of Tissue-engineered Skin for Repairing Wounds
Official Title
Multicenter Clinical Randomized Controlled Trials on Rapid Construction of Tissue-engineered Skin for Repairing Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A wound comprises a break in epithelial continuity and disruption of structure and function of underlying tissues, the treating and repairing is always a great challenge in clinical practice. The complex healing process make the wound easy to get a tendency of nonhealing and result in a heavy burden of life quality. Nowadays surgical repairing is still the main method, but there was still no effective and satisfy outcomes. Because none of the treatments could repair skin both on structure and function. Now the investigators provide a quick and effective method to rebuilt complete structure and function of the skin based on tissue-engineered skin technology. To further test the efficacy and safety of this new method, the investigators propose a prospective randomized controlled multicenter trial to compare this method with traditional skin graft.
Detailed Description
A wound comprises a break in epithelial continuity and disruption of structure and function of underlying tissues, the treating and repairing is always a great challenge in clinical practice. The complex healing process make the wound easy to get a tendency of nonhealing and result in a heavy burden of life quality. Nowadays surgical repairing is still the main method, such as traditional split-thickness skin graft, flap transplantation or tissue-engineered substitute transplantation. However, none of these methods could have effective and satisfy outcomes. Because none of these treatments could repair skin on both structure and function. Therefore, as a new treating technology the tissue-engineered skin has been widely used recently and shows good response. As a consequence, the investigators provide a quick and effective method to rebuilt complete structure and function of the skin based on tissue-engineered skin technology. This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells and could greatly reduce the time. To further test the efficacy and safety of this new method, the investigators propose a prospective randomized controlled multicenter trial to compare this method with traditional skin graft. If this method could actually increase wound take rate, improve the skin quality and restore skin function in some extent, it should resolve the problem of wound repair to a large extent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
wound, tissue-engineered skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tissue-engineered skin method
Arm Type
Experimental
Arm Description
This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells
Arm Title
split-thickness skin graft method
Arm Type
Active Comparator
Arm Description
This method is traditional split-thickness skin graft
Intervention Type
Procedure
Intervention Name(s)
tissue-engineered skin method
Intervention Description
This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells
Intervention Type
Procedure
Intervention Name(s)
split-thickness skin graft method
Intervention Description
This method is traditional split-thickness skin graft
Primary Outcome Measure Information:
Title
healing rate
Description
the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements.
Time Frame
postsurgery week 4
Secondary Outcome Measure Information:
Title
wound reducing rate
Description
the rate of wound reducing based on week 4 after surgery
Time Frame
postsurgery week 4
Other Pre-specified Outcome Measures:
Title
recurrence rate
Description
the incidence of ulcer recurrence at postsurgery month 6
Time Frame
postsurgery month 6

10. Eligibility

Sex
All
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who need to skin graft to repair the wound Subjects signed the informed consent in the day of the age of not more than 81 years old (for minors, legal guardian should be signed) Stable vital signs, regular examination showed that subjects could tolerate surgery Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis Understanding and willing to participate in this clinical trial and signed informed consent All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment No other serious diseases conflicts with the trail Wound size between 3 cm2 and 100 cm2, no limited to location Exclusion Criteria: Allergic constitution of enzyme Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease Subjects with mental illness Subjects could not cooperate with the clinical trial personnel to finish trials Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely < 1000 cells/mm3 Subjects could not tolerate surgery Subjects are unlikely to survive in the study period The investigators think that who should not be included Subjects are in or participated in other clinical researchers over the past 12 weeks Subjects are participated in this trial at any time in the past
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Zhu, PI
Phone
86-20-87755766
Ext
8276
Email
zhujiay@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Zhu, doctor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Zhu, PI
Phone
86-20-87755766
Ext
8276
Email
zhujiay@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhicheng Hu, doctor

12. IPD Sharing Statement

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Rapid Construction of Tissue-engineered Skin for Repairing Wounds

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