Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healing Wound
• Intervention / Treatment: Procedure: cell treatment; Procedure: control treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Zhu; Phone Number: 13802751558; Email: zhujiay@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Jiayuan Zhu
      • Contact: Jiayuan Zhu; Phone Number: 13802751558; Email: zhujiay@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cell treatment; Autologous epidermal basal cells were used to treat postoperative nonhealing wounds	Procedure: cell treatment; Autologous epidermal basal cells were used to repair nonhealing postoperative wound
Sham Comparator: control treatment; Conventional method were used to treat postoperative nonhealing wounds	Procedure: control treatment; anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing rate	wound healing rate	postoperative day 7, 14, 21, 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Jiayuan Zhu, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SYSU-FAH-2019286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No