Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

NCT ID: NCT06173908

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

Healing Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cell treatment

Autologous epidermal basal cells were used to treat postoperative nonhealing wounds

Group Type: EXPERIMENTAL

cell treatment

Intervention Type: PROCEDURE

Autologous epidermal basal cells were used to repair nonhealing postoperative wound

control treatment

Conventional method were used to treat postoperative nonhealing wounds

Group Type: SHAM_COMPARATOR

control treatment

Intervention Type: PROCEDURE

anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound

Interventions

cell treatment

Autologous epidermal basal cells were used to repair nonhealing postoperative wound

Intervention Type: PROCEDURE

control treatment

anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhu Jiayuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Zhu

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Jiayuan Zhu

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayuan Zhu

Role: CONTACT

zhujiay@mail.sysu.edu.cn

13802751558

Facility Contacts

Jiayuan Zhu

Role: primary

zhujiay@mail.sysu.edu.cn

13802751558

Other Identifiers

SYSU-FAH-2019286

Identifier Type: -

Identifier Source: org_study_id