Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Best method in management of facial burn scar
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 21, 2020
September 1, 2020
3 years
September 14, 2020
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 COMPARATORprp 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.
fat injection in post burn facial scar
ACTIVE COMPARATORAfter 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.
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
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 .
Eligibility Criteria
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: 29928084BACKGROUNDOzcelik 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
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
wagdi mohamed, lecturer
lecturer
Central Study Contacts
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