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

Unilateral Cleft Lip Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02958306
• Other study ID #: SMohasin
• Status: Terminated
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

Intervention

Biological:
• platelet rich plasma
PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	scar width	scar width through orbicularis oris muscle by ultrasonography	6 months
Primary	scar width	scar width at skin surface via photograph	6months
Secondary	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