Treatment for nonhealing postoperative wounds using autologous epidermal cells

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University

This study is testing whether a new skin cell treatment can help people with stubborn wounds from surgery heal faster when other methods haven’t worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: N/A to 85 Years
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06173908 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of autologous epidermal basal cell suspension in promoting healing for postoperative wounds that have not healed for more than two weeks. The study aims to address the limitations of current treatment options, such as direct suturing and skin grafts, which often result in prolonged healing times and low success rates. By utilizing a cell treatment derived from the epidermis, which contains epidermal stem cells, the trial seeks to improve wound healing outcomes through a multi-center, prospective randomized controlled approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with non-union of surgical incisions persisting for more than two weeks.

Not a fit: Patients with malignant tumors at the wound site, severe uncontrolled diseases, or those on immunosuppressive therapy may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the healing rates of difficult postoperative wounds, reducing recovery time and associated healthcare costs.

How similar studies have performed: While the approach of using autologous epidermal cells is innovative, similar studies have shown promise in enhancing wound healing, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* (1) the age of the subject on the day of signing the informed consent is 18 years old or above;

  (2) the diagnosis was non-union of incision, and the diagnosis criteria of non-union of incision were as follows: non-union of incision \> for 2 weeks after various surgeries;

  (3) patients with stable vital signs, who are proved to be tolerable to surgery by routine examination;

  (4) the patient is in good mental state, can follow the doctor's advice and return to the hospital regularly;

  (5) understand and willing to participate in this clinical trial and provide the signed informed consent

Exclusion Criteria:

* (1) local wound complicated with malignant tumor;

  (2) during the screening period, patients showed immunosuppression due to potential diseases, long-term immunosuppressive therapy or the use of large doses of glucocorticoid (i.e.

  (3) patients with mental diseases;

  (4) patients with serious uncontrolled diseases or acute systemic infections and other serious visceral diseases such as heart, lung and brain diseases;

  (5) if the researcher considers the inclusion inappropriate;

  (6) the patients were pregnant women, fertile women who did not take appropriate contraceptive measures, lactating women during the screening period or women who planned to become pregnant within 1 month after the end of the study;

  (7) the patient participated in this study at any time in the past and the patient is participating in other clinical trials.

Where this trial is running

Guangzhou, Guangdong

• Jiayuan Zhu — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jiayuan Zhu — First Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Jiayuan Zhu

Conditions Healing Wound