Back to resultsMesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
Primary Purpose
MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
The pleiotropic factor derived from mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
No intervention
The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04538885
First Posted
August 30, 2020
Last Updated
September 7, 2020
Sponsor
Chinese PLA General Hospital
Collaborators
Gansu Provincial Maternal and Child Health Care Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04538885
Brief Title
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
Official Title
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2020 (Anticipated)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Gansu Provincial Maternal and Child Health Care Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
experimental group
Arm Type
Experimental
Arm Description
The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2)
Intervention Type
Biological
Intervention Name(s)
The pleiotropic factor derived from mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing time and healing rate
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirong Li, doctor
Phone
010-66936345
Email
meirong811225@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If any researcher needs it, you can apply to us
Learn more about this trial
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
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