Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar

NCT ID: NCT04557514

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-12-01

Brief Summary

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Best method in management of facial burn scar

Detailed Description

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The stages of wound healing:proceed in an organized way and follow four processes: hemostasis, inflammation, proliferation and maturation. Although the stages of wound healing are linear, wounds can progress backward or forward depending on internal and external patient conditions. The four stages of wound healing are:Hemostasis Phase Hemostasis is the process of the wound being closed by clotting. Hemostasis starts when blood leaks out of the body. Inflammatory Phase Inflammation is the second stage of wound healing and begins right after the injury when the injured blood vessels leak transudate (made of water, salt, and protein) causing localized swelling. Proliferative Phase The proliferative phase of wound healing is when the wound is rebuilt with new tissue made up of collagen and extracellular matrix. Maturation Phase Also called the remodeling stage of wound healing, the maturation phase is when collagen is remodeled from type III to type I and the wound fully closes.

Fat Injection In Facial burn scar:The effects of the lipofilling can be seen starting from 3 weeks after the procedure, in terms of better scar color, pliability, thickness, relief, itching, pain, scar vascularization and pigmentation. Indeed, autologous fat grafting makes the skin softer, more flexible and extensible; besides, the color seems similar to the surrounding unharmed skin.

Platelet Rich Plasma In Facial burn scar: Impaired wound-healing and a long treatment course in severe burns as well as secondary complications originating from uncovered wounds motivate research to accelerate the wound-healing process and speed up re-epithelialization in burn patients.

Conditions

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Burn Scar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet rich plasma injection in post burn facial scar

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.

Group Type ACTIVE_COMPARATOR

platelet rich plasma injection in post burn facial scar

Intervention Type PROCEDURE

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 scar

Intervention Type PROCEDURE

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 scar

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.

Group Type ACTIVE_COMPARATOR

platelet rich plasma injection in post burn facial scar

Intervention Type PROCEDURE

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 scar

Intervention Type PROCEDURE

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 .

Interventions

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platelet rich plasma injection in post burn facial scar

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

Intervention Type PROCEDURE

fat 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 .

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients Less Than 15 Yrs Old
2. Patients More Than 60 Yrs Old
3. Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients)
4. Patients With Burn Scar In Any Site Of Body Other Than Face
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mostafa Shehata Mohammed

official investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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wagdi mohamed, lecturer

Role: STUDY_DIRECTOR

lecturer

Central Contacts

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abdelrahman mostafa shehata, doctor

Role: CONTACT

01020905498

youssef saleh, professor

Role: CONTACT

01001166118

References

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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.

Reference Type BACKGROUND
PMID: 29928084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27262706 (View on PubMed)

Other Identifiers

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facial burn scar

Identifier Type: -

Identifier Source: org_study_id

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