Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

Healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173908
• Other study ID #: SYSU-FAH-2019286
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Jiayuan Zhu
• Phone: 13802751558
• Email: zhujiay[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds.

At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.

Description:

Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds, show the incision infection, effusion, hemorrhage, empyema, skin lesions and skin defect. It has a high morbidity and the treatment cycle is long, the social and economic burden is heavy.

At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Therefore, how to improve the wound healing rate is an urgent problem to be solved. The present study indicated that the disturbance of wound microenvironment was the main reason for the wound healing. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing Wound
• Wounds and Injuries

Intervention

Procedure:
• cell treatment
Autologous epidermal basal cells were used to repair nonhealing postoperative wound
• control treatment
anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound

Locations

Country	Name	City	State
China	Jiayuan Zhu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing rate	wound healing rate	postoperative day 7, 14, 21, 28
Secondary	healing time	wound healing time	when the wound was complete healed,through study completion, an average of 1 or 2 weeks
Secondary	recurrence rate	recurrence rate	postoperative month 3
Secondary	Wound reduction rate	Wound reduction rate	postoperative day 7, 14, 21, 28