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
Verified date | February 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Oral and Dental Medicine | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Fayoum University |
Egypt,
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 |
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