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

NCT ID: NCT07112898

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-01-15

Brief Summary

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.

Conditions

Skin Transplantation; Reconstructive Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group PRP

Patients in this group received autologous platelet-rich plasma (PRP) applied to both the recipient wound bed and the graft before graft placement, during full-thickness skin grafting for facial or neck defects.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma (PRP)

Intervention Type: PROCEDURE

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.

Group Control

Patients in this group underwent standard full-thickness skin grafting on the face or neck without PRP application.

Group Type: ACTIVE_COMPARATOR

Standard Skin Grafting

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Autologous PRP; Conventional Full-Thickness Skin Graft

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Irfan Jamil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lahore General Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

LahoreGeneralH5

Identifier Type: -

Identifier Source: org_study_id