Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale

NCT04781348 | Completed Phase 4 DMC

• 1 other identifier: 1957
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background: - Burn injuries always leave behind some permanent marks on the body of a victim. For the treatment of these scars, digital photography along with scar scales instrument are an important instrument for the patient's evaluation and finally for the follow-up of scars. Clinical evaluation of the patient after the use of Platelet concentration that it is a beneficial treatment which affects both on hard and soft tissues healing because of having growth factors deposited in PRP. Therefore, it can be used as an alternative to surgery which promotes safe and natural healing in such patients. Objectives: - 1\. To determine the efficacy of Platelet Rich Plasma plus fat grafting as compared to fat grafting alone on the Vancouver scar scale. Methodology: - An experimental controlled comparison trial study will be done on burn patients, admitted for recovery at the Plastic surgery department, Civil Hospital Karachi after the approval of the scientific committee and Institutional review board of Dow University of Health Sciences, Karachi. The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting. The sample size of the study will be 52(26 in each group). Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months. Assessment of scar with Vancouver Scars Scale (VSS) will be done. The association of the PRP plus fat cells group and control group will be done by applying Chi-square statistical test. P-Value will be set for statistical significance level at \<0.05.

Conditions

Burn

Keywords

Platelet-rich plasma; Fat grafting; Efficacy; wound healing; Burns scar; Regeneration

Outcome Measures

Primary Outcomes (1)

• Assessment of change in scar

  Assessment of scar with Vancouver Scars Scale

  Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months.

Study Arms (2)

Platelet Rich Plasma and fat grafting

EXPERIMENTAL

Group will receive Platelet Rich Plasma plus fat grafting

Procedure: Platelet Rich Plasma plus fat grafting

Fat grafting

EXPERIMENTAL

Group will receive only fat grafting

Procedure: Platelet Rich Plasma plus fat grafting

Interventions

Platelet Rich Plasma plus fat grafting PROCEDURE

The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting.

Fat grafting; Platelet Rich Plasma and fat grafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All the buns patients of either age or sex coming with burn scar for plastic surgery.
• Give consent for this study
• Aesthetically not pleasant
• Exposed body parts
• Mature scar

You may not qualify if:

• Immature scar
• Systematic illness.
• Sepsis
• Psychiatric illness.
• Pregnant women

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Plastic Surgery Department, Civil Hospital Karachi (CHK)

Karachi, Sindh, 75950, Pakistan

Location

Related Publications (8)

• Bendinelli P, Matteucci E, Dogliotti G, Corsi MM, Banfi G, Maroni P, Desiderio MA. Molecular basis of anti-inflammatory action of platelet-rich plasma on human chondrocytes: mechanisms of NF-kappaB inhibition via HGF. J Cell Physiol. 2010 Nov;225(3):757-66. doi: 10.1002/jcp.22274.

  PMID: 20568106 BACKGROUND

• Nakamura S, Ishihara M, Takikawa M, Murakami K, Kishimoto S, Nakamura S, Yanagibayashi S, Kubo S, Yamamoto N, Kiyosawa T. Platelet-rich plasma (PRP) promotes survival of fat-grafts in rats. Ann Plast Surg. 2010 Jul;65(1):101-6. doi: 10.1097/SAP.0b013e3181b0273c.

  PMID: 20548232 BACKGROUND

• Cervelli V, Gentile P, Scioli MG, Grimaldi M, Casciani CU, Spagnoli LG, Orlandi A. Application of platelet-rich plasma in plastic surgery: clinical and in vitro evaluation. Tissue Eng Part C Methods. 2009 Dec;15(4):625-34. doi: 10.1089/ten.TEC.2008.0518.

  PMID: 19231923 BACKGROUND

• Cervelli V, Gentile P, De Angelis B, Calabrese C, Di Stefani A, Scioli MG, Curcio BC, Felici M, Orlandi A. Application of enhanced stromal vascular fraction and fat grafting mixed with PRP in post-traumatic lower extremity ulcers. Stem Cell Res. 2011 Mar;6(2):103-11. doi: 10.1016/j.scr.2010.11.003. Epub 2010 Nov 30.

  PMID: 21195687 BACKGROUND

• Man D, Plosker H, Winland-Brown JE. The use of autologous platelet-rich plasma (platelet gel) and autologous platelet-poor plasma (fibrin glue) in cosmetic surgery. Plast Reconstr Surg. 2001 Jan;107(1):229-37; discussion 238-9. doi: 10.1097/00006534-200101000-00037.

  PMID: 11176628 BACKGROUND

• Chandarana S, Fung K, Franklin JH, Kotylak T, Matic DB, Yoo J. Effect of autologous platelet adhesives on dermal fat graft resorption following reconstruction of a superficial parotidectomy defect: a double-blinded prospective trial. Head Neck. 2009 Apr;31(4):521-30. doi: 10.1002/hed.20999.

  PMID: 19156832 BACKGROUND

• Brusselaers N, Pirayesh A, Hoeksema H, Verbelen J, Blot S, Monstrey S. Burn scar assessment: a systematic review of different scar scales. J Surg Res. 2010 Nov;164(1):e115-23. doi: 10.1016/j.jss.2010.05.056. Epub 2010 Jun 16.

  PMID: 20828761 RESULT

• Jin R, Zhang L, Zhang YG. Does platelet-rich plasma enhance the survival of grafted fat? An update review. Int J Clin Exp Med. 2013 Apr 12;6(4):252-8. Print 2013.

  PMID: 23641301 RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Group-I: will receive only fat grafting; Group-II: will receive Platelet Rich Plasma and fat grafting

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)