NCT04557514

Brief Summary

Best method in management of facial burn scar

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

September 14, 2020

Last Update Submit

September 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 0-2 mm 1 2-5 mm 2 \>5 mm 3

    3 months

Study Arms (2)

platelet rich plasma injection in post burn facial scar

ACTIVE COMPARATOR

prp in subgroup allocation 1:1 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes Do not chill the blood at any time before or during platelet separation. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.

Procedure: platelet rich plasma injection in post burn facial scarProcedure: fat injection in post burn facial scar

fat injection in post burn facial scar

ACTIVE COMPARATOR

After aspiration of the fatty tissue, it is important that nonviable components of the aspirate, such as oil, blood, and local anesthetics are removed and, at the same time, the quality, integrity, and viability of the adipocytes and the inherent mesenchymal stem cells in the aspirate be maintained. Processing techniques are sedimentation , filtering and washing There is no consensus as to the optimal method of fat graft preparation.

Procedure: platelet rich plasma injection in post burn facial scarProcedure: fat injection in post burn facial scar

Interventions

2 spins\>\>\> 1. st spin (separate plasma from blood) 2500 for 10 minutes 2. nd spin (separate platelet rich part of plasma) 1500 for 10 minutes Taking lower part (platelet rich plasma ) Injection under scar after rigotomy

fat injection in post burn facial scarplatelet rich plasma injection in post burn facial scar

Anesthesia : general or local Lipoaspirate from abdomen or thigh using adrenaline(1\\1000000) + ringer lactate + zylocaine Liposuction by canula no4 Sediment 3 layers : taking mid layer of fat and omit uppermost and lowermost layers Lipoinjection in fan shaped manner 10-20 cc according to site affected by canula no 1 .

fat injection in post burn facial scarplatelet rich plasma injection in post burn facial scar

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients With Post Burn Facial Scar
  • Age: 15 \_60 Yrs Old
  • Mature Burn Scar (After 3 Months)

You may not qualify if:

  • Patients Less Than 15 Yrs Old
  • Patients More Than 60 Yrs Old
  • Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients)
  • Patients With Burn Scar In Any Site Of Body Other Than Face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bhooshan LS, Devi MG, Aniraj R, Binod P, Lekshmi M. Autologous emulsified fat injection for rejuvenation of scars: A prospective observational study. Indian J Plast Surg. 2018 Jan-Apr;51(1):77-83. doi: 10.4103/ijps.IJPS_86_17.

    PMID: 29928084BACKGROUND
  • Ozcelik U, Ekici Y, Bircan HY, Aydogan C, Turkoglu S, Ozen O, Moray G, Haberal M. Effect of Topical Platelet-Rich Plasma on Burn Healing After Partial-Thickness Burn Injury. Med Sci Monit. 2016 Jun 5;22:1903-9. doi: 10.12659/msm.895395.

    PMID: 27262706BACKGROUND

MeSH Terms

Interventions

CD36 Antigens

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • wagdi mohamed, lecturer

    lecturer

    STUDY DIRECTOR

Central Study Contacts

abdelrahman mostafa shehata, doctor

CONTACT

youssef saleh, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
official investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 21, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share