Clinical trial NCT02958306: Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Unilateral Cleft Lip
Keywords: cleft lip repair
cheiloplasty
PRP
platelet rich plasma
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Fayoum University
First posted: 2016-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: scar width
timeFrame: 6 months
measure: scar width
timeFrame: 6months
Secondary outcomes:
measure: vancouver scar scale
timeFrame: 6 months
Other outcomes:
measure: Philtral ridge length symmetry index
timeFrame: 6months
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
affiliation: Cairo University
name: basma G mousa, professor
role: STUDY_DIRECTOR
References: