Behera Susmita, Mishra Biswajit, Cherian Jerin Jose, Kumar Gunjan, Mahapatra Smita, Mukherjee Aparna, Roy Sudipto, Bagepally Bhavani Shankara, Sahoo Binay Bhusan, Majhi Madan Mohan, ShoganRaj S, Kumar Vijay, Sarkar Arindam, Nellaiappar P
Department of Transfusion Medicine, SCB Medical College, Cuttack, India.
Department of Plastic & Reconstructive Surgery, SCB Medical College, Cuttack, India.
Trials. 2025 Mar 12;26(1):83. doi: 10.1186/s13063-025-08757-2.
Burn wounds are commonly encountered in clinical settings and the management aims at the prevention of mortality and morbidity due to disability. The platelet-rich plasma (PRP) is blood-derived biomaterial that is enriched with growth factors and cytokines that facilitate wound healing. The PRP has proven its efficacy in various other wounds, but its role in post-burn raw areas and graft take has not been validated. This proposed multicentre randomized controlled trial aims to evaluate the efficacy and safety of platelet-rich plasma as an adjunct therapy to split-thickness skin graft in burn patients with granulating raw wounds.
METHOD/DESIGN: This trial is an investigator-initiated, double-blind multicentre, randomized controlled parallel arm trial alongside trial cost-effectiveness analysis. Granulating deep second-degree and third-degree burns affecting 3-20% of total body surface area (TBSA) at 10-14th post-burn day will be included in the study. A total of 550 patients (275 in each group) will be randomized to receive either standard skin graft or allogenic PRP with skin graft treatment. The primary endpoint will be the mean percentage of graft-take on the 14th postoperative day. The result will be analyzed by two independent assessors who are blinded to the study. Secondary endpoints include (a) time taken for complete wound healing; (b) frequency of adverse events; (c) follow-up with scar index at 3 months, 6 months, and 1 year using the Patient and Observer Scar Assessment Scale (POSAS) score; (d) cost-effectiveness analysis of the intervention compared to the comparator; and (e) to estimate in a subset of participants the association between growth factor levels (PDGF BB and TGF ß-1) of activated PRP and clinical response.
The proposed trial will be expected to verify the efficacy and safety of PRP for split-thickness skin graft (STSG) in deep second-degree or third-degree granulating wounds of burn patients based on the outcome of the study.
烧伤创面在临床中较为常见，其治疗目的是预防因残疾导致的死亡率和发病率。富血小板血浆（PRP）是一种源自血液的生物材料，富含促进伤口愈合的生长因子和细胞因子。PRP已在其他各类伤口中证实了其有效性，但其在烧伤后创面及植皮成活方面的作用尚未得到验证。这项拟议中的多中心随机对照试验旨在评估富血小板血浆作为辅助治疗手段，用于治疗有肉芽创面的烧伤患者进行中厚皮片移植时的有效性和安全性。
方法/设计：本试验是一项由研究者发起的、双盲多中心、随机对照平行组试验，并同时进行试验成本效益分析。研究将纳入烧伤后10 - 14天、深二度和三度烧伤面积占总体表面积（TBSA）3 - 20%且有肉芽形成的患者。总共550名患者（每组275名）将被随机分组，分别接受标准皮肤移植或异体PRP联合皮肤移植治疗。主要终点将是术后第14天植皮成活的平均百分比。结果将由两名对研究不知情的独立评估者进行分析。次要终点包括：（a）伤口完全愈合所需时间；（b）不良事件发生频率；（c）使用患者和观察者瘢痕评估量表（POSAS）评分，在3个月、6个月和1年时对瘢痕指数进行随访；（d）与对照相比，干预措施的成本效益分析；（e）在一部分参与者中评估活化PRP的生长因子水平（血小板源性生长因子BB和转化生长因子β-1）与临床反应之间的关联。
根据研究结果，预期拟议中的试验将验证PRP用于烧伤患者深二度或三度肉芽创面中厚皮片移植（STSG）的有效性和安全性。
