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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04557514
Other study ID # facial burn scar
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 1, 2023

Study information

Verified date September 2020
Source Assiut University
Contact abdelrahman mostafa shehata, doctor
Phone 01020905498
Email abdelrahmanshehata084@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Best method in management of facial burn scar


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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 .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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