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

NCT ID: NCT04538885

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2021-05-30

Brief Summary

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.

Conditions

MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2)

Group Type: EXPERIMENTAL

The pleiotropic factor derived from mesenchymal stem cells

Intervention Type: BIOLOGICAL

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.

Interventions

The pleiotropic factor derived from mesenchymal stem cells

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue；

2. Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；

3. 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

4. Men or women older than 17 years old and younger than 75 years old;

5. Psychologically stable, able to complete the test process.

Exclusion Criteria

1. 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;

2. Surgical incision with purulent infection, local purulent secretions can be seen;

3. Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;

4. Patients with diabetes;

5. Glucocorticoid users;

6. Patients with immune dermatosis;

7. Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;

8. Psycho-psychological disorders and poor compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaobing Fu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Meirong Li, doctor

Role: CONTACT

meirong811225@126.com

010-66936345

Other Identifiers

CHIN-PLAGH-MP-04

Identifier Type: -

Identifier Source: org_study_id