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

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.

Study Overview

• Status: Unknown
• Conditions: MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
• Intervention / Treatment: Biological: The pleiotropic factor derived from mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; No intervention
Experimental: experimental group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Gansu Provincial Maternity and Child-Care Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: CHIN-PLAGH-MP-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If any researcher needs it, you can apply to us

Drug and device information, study documents

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