Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision

Study Overview
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Brief Summary
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Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.

Official Title
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Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision

Conditions
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MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision

Intervention / Treatment
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* Biological: The pleiotropic factor derived from mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue； Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week； There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered Men or women older than 17 years old and younger than 75 years old; Psychologically stable, able to complete the test process. Exclusion Criteria: Wound size>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity; Surgical incision with purulent infection, local purulent secretions can be seen; Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture; Patients with diabetes; Glucocorticoid users; Patients with immune dermatosis; Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion; Psycho-psychological disorders and poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>No intervention | |
| Experimental: experimental group<br>The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2) | Biological: The pleiotropic factor derived from mesenchymal stem cells<br>* The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2), and then the wound was covered with a foam dressing; the dressing was changed every 3 days to reach clinical healing as the end of the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing time and healing rate | Judgment criteria for incision recovery (4 weeks after treatment): Cure: the patient's incision is completely or basically healed, and the surrounding skin returns to normal; markedly effective: the patient's incision is recovered> 1/2, and the surrounding skin returns to normal; effective: the patient's incision is recovered <1 /2, and the surrounding skin returned to normal; invalid: the patient's incision had no obvious changes, and the surrounding skin color had no obvious improvement. | 1 month |