Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healing Wound

Intervention / Treatment
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* Procedure: cell treatment
* Procedure: control treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |