Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck

Обзор

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.

Вмешательства

• Процедура Platelet-Rich Plasma (PRP)
  Autologous PRP (approximately 4-6 mL) will be prepared using a double centrifugation technique and activated with 10% calcium gluconate. It will be administered by injecting 0.1-0.2 mL/cm² subdermally into the recipient bed and intradermally into the graft prior to placement.
• Процедура Standard Skin Grafting
  Grafts will be placed on a clean, vascularized wound bed, secured with nonabsorbable sutures, and covered with standard postoperative dressings. No PRP will be applied.

Первичные конечные точки

• Percentage of Graft Uptake at Day 7 Postoperatively [Срок оценки: 7th postoperative day]

Вторичные конечные точки (2)

• Proportion of Patients with Graft Failure (0% Uptake) [Срок оценки: 7th postoperative day]
• Local Graft Site Infection [Срок оценки: 7th postoperative day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Lahore General Hospital, Lahore — Lahore

Идентификаторы

NCT: NCT07112898 · LahoreGeneralH5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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