Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFujian Medical University Union Hospital
About this trial
The goal of this clinical trial is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cell (hUCMSC) therapy in patients undergoing medium-thickness skin grafts for donor site wounds. The study aims to answer the following main questions:
* Question 1: Does hUCMSC therapy improve the healing quality and speed of donor site wounds in comparison to standard treatment? * Question 2: Does hUCMSC therapy reduce scar formation in the donor site wounds?
Participants in this study will undergo medium-thickness skin grafts, and those in the treatment group will receive hUCMSC therapy. The main tasks for participants will involve regular follow-up visits, monitoring of wound healing progress, and assessment of any potential side effects or complications associated with the therapy.
In order to evaluate the effectiveness of hUCMSC therapy, researchers will compare the treatment group receiving hUCMSC therapy with a control group that receives standard treatment alone. The aim is to determine if the use of hUCMSC therapy leads to improved healing outcomes and reduced scar formation compared to the standard treatment group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients between 18 and 60 years old with extensive scars, large benign tumors, or fresh wounds on the body surface.
Patients who undergo medium-thickness skin graft surgery (donor site can be from the thigh, abdomen, or back).
Participants who have a thorough understanding of the study objectives, significance, implementation plan, potential benefits, risks involved, measures to address risks, and the rights and obligations of the subjects (including privacy protection and the right to withdraw), and are willing to participate in this clinical study and can cooperate effectively.
Disqualifiers
Hypertension, hypotension, heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis).
Liver or kidney dysfunction.
Infectious diseases (including viral hepatitis, syphilis, HIV/AIDS, etc.).
Venous thrombosis, thoracic or abdominal aortic aneurysm, aortic dissection.
Trial design
Design model
Parallel
Treatments tested in this trial
human umbilical cord mesenchymal stem cells
Procedure/SurgeryAfter the completion of the donor site harvesting in the experimental group, allogeneic umbilical cord mesenchymal stem cells are injected into the deep layer of the de-epithelialized area and the surrounding 0.5cm subcutaneous region. After the injection, the wound is covered and dressed with conventional dressings.
blank solvent
Procedure/SurgeryAfter the completion of the donor site harvesting in the experimental group, the de-epithelialized area and the surrounding 0.5cm subcutaneous region is injected an equal volume of blank solvent for stem cell suspension in the control group. After the injection, the wound is covered and dressed with conventional dressings.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: human umbilical cord mesenchymal stem cellsExperimental treatment 1 intervention
Group B: blank solventPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to epithelialization of the skin wound
Record the size of the donor site wound at each follow-up time point and document it with photographs.
Time frame
12 months2
Observation of scar formation
Record the height and erythema of the donor site scar at each follow-up time point and document them with photographs. It will be assessed using, Vancouver scar scale at time of presentation and at 12 months after the intervention. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. Vancouver Scar Scale is a 13 points scale and includes four parameters, pigmentation, vascularity pliability and height of scar.13 It is an objective scale and examining doctor will assess and record score out of 13. Lesser the score better is the scar
Time frame
12 monthsSecondary outcomes
1
Itching at wound site
It will be assessed at the time of presentation and at 12 months after the intervention using severity of pruritus scale. It is 4 point rating scale from 0 (no itch) to 3(severe itch disturbing the sleep) assessing severity of pruritus within 24-hours recall period. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented.
Time frame
12 months2
Pain At scar Site
Patient will be asked to rate his/her current, best and worst pain level over past 24 hours on scale of 0 (no pain) to 10 (worst pain imaginable). Pain at scar site will be assessed at time of presentation and then at 12 months after start of the treatment. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. This scale is chosen due to its high feasibility and good compliance.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov