Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair

Evaluation of the Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty: A Randomized Clinical Trial

The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

Study Overview

• Status: Terminated
• Conditions: Unilateral Cleft Lip
• Intervention / Treatment: Biological: platelet rich plasma

Detailed Description

PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values. PRP is made by centrifugation of whole blood (drawn from a peripheral vein and stored in an acid citrate dextrose solution A (ACD-A) anticoagulant), which separates the various components of blood by their specific weight and increases the concentration of platelets.

Platelets are a rich source of the complex group of proteins called growth factors (GFs) involved in natural wound healing and in regeneration of injured tissues. GFs are active signals for attracting stem cells into the site of injury and triggering proliferation of these cells. PRP limit inflammation, interacting with macrophages to improve tissue healing and regeneration, promote new capillary growth, and accelerate epithelialization. Platelets in PRP also play a role in host defense mechanism at the wound site by producing signaling proteins that attract macrophages; PRP also may contain a small number of leukocytes that synthesize interleukins as part of a non-specific immune response. Previous studies of PRP have demonstrated antimicrobial activity against Escherichia coli, Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, Candida albicans, and Cryptococcus neoforma. So, PRP is effective in soft tissue healing, having no side effect and showed excellent healing score in skin wound healing.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Oral and Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with nonsyndromic cleft lip
• Primary, unilateral, complete or incomplete cleft lip
• Patient's age younger than six months
• Lip repair performed by one craniofacial surgeon
• Completeness of medical records including preoperative and postoperative photographs at approximately 6 months after surgery

Exclusion Criteria:

• Patients with syndromic cleft lip
• Secondary lip treatment (previous operated cases)
• Bilateral cleft lip
• Patient older than six months
• Associated Cardiac anomalies
• Any systemic condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: platelet rich plasma; autologous blood product	Biological: platelet rich plasma; PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values; Other Names: PRP
No Intervention: no platelet rich plasma; control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scar width	scar width through orbicularis oris muscle by ultrasonography	6 months
scar width	scar width at skin surface via photograph	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vancouver scar scale	VSS has four parameters, including vascularity, pigmentation, thickness, and pliability giving a range of 0 to 13 in the total score with 0 representing normal skin	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Philtral ridge length symmetry index	Philtral ridge length was measured on the non-cleft side and a correspondent length on the reconstructed cleft side from nasal sill to the peak of Cupid's bow . Philtral ridge symmetry index was calculated as follow:- (Cleft side component value)/(Non clefted side component value)×100	6months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Fayoum University
• Investigators: Study Director: basma G mousa, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: platelet rich plasma; PRP; cleft lip repair; cheiloplasty
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: SMohasin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided