Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair
Primary Purpose
Unilateral Cleft Lip
Status
Terminated
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma
Sponsored by
About this trial
This is an interventional prevention trial for Unilateral Cleft Lip focused on measuring cleft lip repair, cheiloplasty, PRP, platelet rich plasma
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
Sites / Locations
- Faculty of Oral and Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
platelet rich plasma
no platelet rich plasma
Arm Description
autologous blood product
control
Outcomes
Primary Outcome Measures
scar width
scar width through orbicularis oris muscle by ultrasonography
scar width
scar width at skin surface via photograph
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02958306
First Posted
November 3, 2016
Last Updated
February 24, 2019
Sponsor
Cairo University
Collaborators
Fayoum University
1. Study Identification
Unique Protocol Identification Number
NCT02958306
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
December 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Fayoum University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cleft Lip
Keywords
cleft lip repair, cheiloplasty, PRP, platelet rich plasma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
platelet rich plasma
Arm Type
Experimental
Arm Description
autologous blood product
Arm Title
no platelet rich plasma
Arm Type
No Intervention
Arm Description
control
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values
Primary Outcome Measure Information:
Title
scar width
Description
scar width through orbicularis oris muscle by ultrasonography
Time Frame
6 months
Title
scar width
Description
scar width at skin surface via photograph
Time Frame
6months
Secondary Outcome Measure Information:
Title
vancouver scar scale
Description
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
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Philtral ridge length symmetry index
Description
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
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
basma G mousa, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair
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