Rapid Construction of Tissue-engineered Skin for Repairing Wounds

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Feb 22, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a new method for repairing wounds using tissue-engineered skin. Traditional skin grafts can sometimes be slow and not always effective, so researchers are exploring a quicker, more effective way to rebuild both the structure and function of the skin. The goal is to see if this new method works better than the standard approach in helping wounds heal properly.

To participate in this trial, individuals must be in need of a skin graft for a wound that is between 3 and 100 square centimeters in size. Participants should be 81 years old or younger and able to tolerate surgery. They must also be mentally stable and willing to follow the study's guidelines. Throughout the trial, participants will receive regular check-ups, and women will need to use effective birth control during the study. This trial is currently recruiting participants, and everyone involved will be helping to test a potentially better way to heal wounds.

Gender

ALL

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