Unilateral Cleft Lip
Conditions
Keywords
cleft lip repair, cheiloplasty, PRP, platelet rich plasma
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.
Interventions
BIOLOGICALplatelet rich plasma
PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values
Sponsors
Fayoum University
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| scar width | 6 months | scar width through orbicularis oris muscle by ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Philtral ridge length symmetry index | 6months | 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 |
Countries
Egypt
Outcome results
None listed