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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02958306
Other study ID # SMohasin
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2016
Est. completion date February 2018

Study information

Verified date February 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Terminated
Enrollment 24
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 3 Months to 6 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Oral and Dental Medicine Cairo

Sponsors (2)

Lead Sponsor Collaborator
Cairo University Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Philtral ridge length symmetry index 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 6months
Primary scar width scar width through orbicularis oris muscle by ultrasonography 6 months
Primary scar width scar width at skin surface via photograph 6months
Secondary 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 6 months
See also
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Completed NCT05334602 - The Effect of Use of Dermal Fat Graft as a Barrier Membrane N/A
Completed NCT05080855 - Comparison of Techniques in Repair of Unilateral Cleft Lip N/A
Not yet recruiting NCT05940389 - Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches N/A