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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04557514

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Best method in management of facial burn scar

Condition or Disease	Intervention/Treatment	Phase
Burn Scar	Procedure: platelet rich plasma injection in post burn facial scar Procedure: fat injection in post burn facial scar	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Study Between Fat Injection And Platelet Rich Plasma IN Post Burn Facial Scar Clinical And Histopathological Assessment

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: platelet rich plasma injection in post burn facial scar 2 spins>>> st spin (separate plasma from blood) 2500 for 10 minutes nd spin (separate platelet rich part of plasma) 1500 for 10 minutes Taking lower part (platelet rich plasma ) Injection under scar after rigotomy 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 .
Active Comparator: 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.	Procedure: platelet rich plasma injection in post burn facial scar 2 spins>>> st spin (separate plasma from blood) 2500 for 10 minutes nd spin (separate platelet rich part of plasma) 1500 for 10 minutes Taking lower part (platelet rich plasma ) Injection under scar after rigotomy 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 .

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: platelet rich plasma injection in post burn facial scar

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

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 .

Active Comparator: 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.

Procedure: platelet rich plasma injection in post burn facial scar

Procedure: fat injection in post burn facial scar

Outcome Measures

Primary Outcome Measures

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 0-2 mm 1 2-5 mm 2 >5 mm 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: wagdi mohamed, lecturer, lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Abdelrahman Mostafa Shehata Mohammed, official investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04557514

Other Study ID Numbers:

facial burn scar

First Posted:

Sep 21, 2020

Last Update Posted:

Sep 21, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burns

Study Results

No Results Posted as of Sep 21, 2020