Mesenchymal stem cell gel for improving healing of burn skin grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, parallel-controlled trial enrolling 90 adult burn patients undergoing autologous medium-thick skin grafting. Participants are randomized 1:1:1 to receive a low-dose stem cell gel, a high-dose stem cell gel, or a placebo gel applied to donor/treated skin sites, with 30 patients per group. All groups receive the same surgical and postoperative care and attend regular follow-up visits per protocol. The trial is conducted at a single center and focuses on wound healing outcomes after graft harvest and transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary participation and signing of the informed consent form;
2. Burn patients, subjects requiring autologous skin grafting;
3. Age 18 to 65 years old, gender not restricted;
4. During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
5. Skin burn area \< 30% of total body surface area (TBSA);
6. The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
7. The area of the excised skin flap ≥ 90 cm2;
8. Able to cooperate with this study protocol and accept regular postoperative follow-up visits.

Exclusion Criteria:

1. Those allergic to sodium alginate (gel component);
2. Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
3. Subjects with severe systemic diseases (judged by the researchers);
4. Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
5. Pregnant or lactating women;
6. Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
7. Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
8. Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
9. Subjects with a history of malignant tumors;
10. Subjects who have participated in other clinical studies for less than 3 months;
11. Subjects with mental disorders and without self-awareness, unable to express clearly;
12. Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
13. Subjects with infectious diseases (any one of the four items positive in the test);
14. Subjects with other severe systemic diseases;
15. Other subjects that the researchers consider not eligible for inclusion.

Where it's running

• The First Affiliated Hospital of Xinxiang Medical College
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: Wenjie Ren
• Email: 13937354075@163.com
• Phone: 13937354075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.