Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair
- Conditions
- Unilateral Cleft Lip
- Interventions
- Biological: platelet rich plasma
- Registration Number
- NCT02958306
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description platelet rich plasma platelet rich plasma autologous blood product
- Primary Outcome Measures
Name Time Method scar width 6months scar width at skin surface via photograph
- Secondary Outcome Measures
Name Time Method vancouver scar scale 6 months 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
Trial Locations
- Locations (1)
Faculty of Oral and Dental Medicine
🇪🇬Cairo, Egypt