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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

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.

Official Title
-----------------
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

Conditions
-----------------
Unilateral Cleft Lip

Intervention / Treatment
-----------------
* Biological: platelet rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich plasma<br>autologous blood product | Biological: platelet rich plasma<br>* PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values<br>* Other names: PRP;|
| No Intervention: no platelet rich plasma<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRP, cleft lip repair, cheiloplasty, platelet rich plasma