A prospective single center non randomized clinical trial of autologous skin cells with platelet rich plasma for diabetic ulcer and trauma injuries patients

一项前瞻性单中心非随机临床试验,研究自体皮肤细胞联合富血小板血浆治疗糖尿病溃疡和创伤患者的疗效。

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Abstract

Split-thickness skin grafts (SSG) for wound treatment has drawbacks, including trauma during skin harvesting, limited availability of healthy skin, pain, scarring, and suitability concerns for certain patients. However, "skin cell drop" presents a promising solution. This fully autologous therapy eliminates rejection and contamination risks, while promoting wound healing with platelet-rich plasma (PRP). Harvested from the patient's own skin biopsy in bedside ward setting, these cells seamlessly integrate into the skin, overcoming many limitations of SSG. This study was conducted to determine the adverse effect and wound healing rate of autologous skin cells with PRP (skin cell drop) in diabetic ulcer and trauma injuries. A prospective, single-centre clinical trial was conducted at Hospital Canselor Tuanku Muhriz from December 2021 to December 2022. The study enrolled total of 7 participants, 2 with traumatic wounds and 5 with diabetic ulcers, using random sampling. After obtaining informed consent, a 1 cm(2) skin biopsy was harvested from a concealed area. The skin sample was suspended in PRP, and applied to the wound within 4-6 h. Follow-up assessments were conducted at specified intervals up to 12 weeks, evaluating demographics, medical history, wound size, vital signs, visual analog scale (VAS). 7 patients were included in this study with 5 patients were diabetic ulcers while another 2 patients were in trauma wound. No significant difference in the CRP and tWBC after treatment, but significant reduction in VAS pain score were noted as early as 5 days. No significant association between the type of wound (diabetic ulcers or Trauma) and wound healing rate. There is a significant reduction in ulcer size in diabetic ulcers post 21, 35, 49 and 77 days of treatment (p < 0.05). The 'skin cell drop' approach appears safe and effective for treating diabetic ulcers and trauma wounds, with significant reductions in ulcer size. Further research with larger sample sizes and longer follow-up is warranted to validate these results.

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