Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

NCT06173908 | Unknown

• 1 other identifier: SYSU-FAH-2019286
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (1)

• healing rate

  wound healing rate

  postoperative day 7, 14, 21, 28

Secondary Outcomes (3)

• healing time

  when the wound was complete healed，through study completion, an average of 1 or 2 weeks

• recurrence rate

  postoperative month 3

• Wound reduction rate

  postoperative day 7, 14, 21, 28

Study Arms (2)

cell treatment

EXPERIMENTAL

Autologous epidermal basal cells were used to treat postoperative nonhealing wounds

Procedure: cell treatment

control treatment

SHAM COMPARATOR

Conventional method were used to treat postoperative nonhealing wounds

Procedure: control treatment

Interventions

cell treatment PROCEDURE

Autologous epidermal basal cells were used to repair nonhealing postoperative wound

cell treatment

control treatment PROCEDURE

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

control treatment

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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;
• (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.

Sponsors & Collaborators

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

Study Sites (1)

Jiayuan Zhu

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

• Jiayuan Zhu

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Zhu

CONTACT

13802751558; 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

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 18, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)