Clinical trial NCT06173908: Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound
Official title: Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healing Wound
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 120
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: healing rate
timeFrame: postoperative day 7, 14, 21, 28
Secondary outcomes:
measure: healing time
timeFrame: when the wound was complete healed，through study completion, an average of 1 or 2 weeks
measure: recurrence rate
timeFrame: postoperative month 3
measure: Wound reduction rate
timeFrame: postoperative day 7, 14, 21, 28
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jiayuan Zhu
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Jiayuan Zhu
role: PRINCIPAL_INVESTIGATOR
References: