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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996614
Collaborator
(none)
40
2
16.1

Study Details

Study Description

Brief Summary

  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. To evaluate the effect of PRP on wound healing on skin graft donor site.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PRP in skin grafts
  • Procedure: conventional methods in skin grafts
N/A

Detailed Description

Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas.

The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned.

Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss.

Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: group with PRP

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

Procedure: PRP in skin grafts
topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas

Experimental: group without PRP

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

Procedure: conventional methods in skin grafts
fixation of the graft with stitches and staplers

Outcome Measures

Primary Outcome Measures

  1. histopathological biopsy from both groups by punch Biopsy (vancouver scale ) [3 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age (15- 60 years).

  2. Post burn Raw area less than 10 % of total body surface area .

  3. Selected donor sites.

Exclusion Criteria:
  1. Raw area due to other causes ( trauma, ischemia,..etc)

  2. Patients with bleeding tendency.

  3. Patients with comorbidities(diabetes, malignancy,..etc)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Mostafa Elsonbaty, prof, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ibrahim Ragab Ibrahim ali, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05996614
Other Study ID Numbers:
  • PRP in skin grafts
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023