Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

NCT05996614 | Unknown

• 1 other identifier: PRP in skin grafts
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas.
2. 2.To evaluate the effect of PRP on wound healing on skin graft donor site.

Conditions

Skin Burn

Outcome Measures

Primary Outcomes (1)

• histopathological biopsy from both groups by punch Biopsy (vancouver scale )

  pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(\>5mm)3

  3 months

Study Arms (2)

group with PRP

EXPERIMENTAL

Group of patients with post burn raw areas treated with application of platelet rich plasma

Procedure: PRP in skin grafts

group without PRP

EXPERIMENTAL

Group of patients with post burn raw areas treated with conventional methods

Procedure: conventional methods in skin grafts

Interventions

PRP in skin grafts PROCEDURE

topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas

group with PRP

conventional methods in skin grafts PROCEDURE

fixation of the graft with stitches and staplers

group without PRP

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age (15- 60 years).
• Post burn Raw area less than 10 % of total body surface area .
• Selected donor sites.

You may not qualify if:

• Raw area due to other causes ( trauma, ischemia,..etc)
• Patients with bleeding tendency.
• Patients with comorbidities(diabetes, malignancy,..etc)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.

  PMID: 34952738 RESULT

MeSH Terms

Conditions

Paresthesia

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Mostafa Elsonbaty, prof

  Assiut University

  STUDY CHAIR

Central Study Contacts

Ibrahim Ragab Ibrahim, master

CONTACT

00201060865454; himo_nimo9@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: August 18, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share