Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair

NCT ID: NCT02958306

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

Detailed Description

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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.

Conditions

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Unilateral Cleft Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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platelet rich plasma

autologous blood product

Group Type EXPERIMENTAL

platelet rich plasma

Intervention Type BIOLOGICAL

PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values

no platelet rich plasma

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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platelet rich plasma

PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohsen

assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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basma G mousa, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of Oral and Dental Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SMohasin

Identifier Type: -

Identifier Source: org_study_id

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