Rapid Construction of Tissue-engineered Skin for Repairing Wounds

NCT02070809 | Unknown DMC

• 1 other identifier: 2013001
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Keywords

wound; tissue-engineered skin

Outcome Measures

Primary Outcomes (1)

• 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.

  postsurgery week 4

Secondary Outcomes (1)

• wound reducing rate

  postsurgery week 4

Other Outcomes (1)

• recurrence rate

  postsurgery month 6

Study Arms (2)

tissue-engineered skin method

EXPERIMENTAL

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

Procedure: tissue-engineered skin method

split-thickness skin graft method

ACTIVE COMPARATOR

This method is traditional split-thickness skin graft

Procedure: split-thickness skin graft method

Interventions

tissue-engineered skin method PROCEDURE

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

tissue-engineered skin method

split-thickness skin graft method PROCEDURE

This method is traditional split-thickness skin graft

split-thickness skin graft method

Eligibility Criteria

• Age: Up to 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jiayuan Zhu, doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Zhu, PI

CONTACT

86-20-87755766; zhujiay@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, vice director of surgery

Study Record Dates

• First Submitted: February 22, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

CN (1)