Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Graft Uptake at Day 7 Postoperatively
研究概览
简要总结
This clinical study aims to evaluate whether applying platelet-rich plasma (PRP), a substance made from a person's own blood, can improve the success of full-thickness skin grafts used to treat facial and neck wounds. Skin grafting is a common reconstructive technique for covering wounds caused by injuries, burns, surgeries, or other conditions. However, skin grafts sometimes do not heal well, leading to complications such as graft failure, infection, or delayed healing, especially in delicate areas like the face and neck.
Platelet-rich plasma contains special healing components called growth factors that may help tissues heal faster and better. These growth factors support new blood vessel formation, reduce swelling, and promote healthy skin regeneration. In this study, participants will be randomly assigned to one of two groups. One group will receive skin grafts along with PRP applied to the wound and graft site, while the other group will receive standard grafting without PRP.
The study will measure how much of the graft survives and integrates into the wound (called "graft uptake") on the 7th day after surgery. It will also assess other early outcomes such as signs of redness (erythema), infection, or blood collection under the graft (hematoma). The hypothesis is that using PRP will lead to better graft healing and fewer complications than using skin grafts alone. The results of this study may help improve recovery and reduce the need for further procedures in patients with facial and neck skin defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years undergoing full-thickness skin grafting for facial or cervical skin defects.
- •Indications for grafting include post-traumatic defects, burns, tumor excision, or revision surgeries.
- •Patients with wound defects of size ranging between 3 cm² and 6 cm², amenable to single-session full-thickness skin grafting.
- •Patients in whom the recipient bed is healthy, vascularized, and free of necrotic tissue at the time of surgery.
排除标准
- •Patients with systemic conditions known to impair wound healing, including uncontrolled diabetes mellitus (HbA1c >8%), severe peripheral vascular disease, collagen vascular disorders, or immunodeficiency.
- •Patients with hematological disorders affecting platelet count or function, including thrombocytopenia (platelet count <150,000/µL), coagulopathies, or platelet dysfunction syndromes.
- •Patients on systemic anticoagulation therapy (e.g., warfarin, DOACs) or corticosteroids within the last 4 weeks.
- •Presence of active local infection or purulent discharge at the recipient or donor site at the time of surgery.
- •History of previous radiation to the grafted site or underlying malignancy with ongoing treatment.
结局指标
主要结局
Percentage of Graft Uptake at Day 7 Postoperatively
时间窗: 7th postoperative day
Graft uptake will be assessed as the percentage of the original wound area successfully covered by the viable graft on the 7th postoperative day. This will be calculated using the formula: Graft Uptake (%) = \[(Original wound area - Denuded area) ÷ Original wound area\] × 100. The denuded area will be determined using sterile measurement tools such as a surgical ruler, grid tracing, or digital planimetry. Based on the uptake percentage, the graft will be categorized qualitatively as: Excellent (\>90%), Good (76-90%), Moderate (50-75%), Poor (\<50%), or Failed (0%).
次要结局
- Proportion of Patients with Graft Failure (0% Uptake)(7th postoperative day)
- Local Graft Site Infection(7th postoperative day)
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital