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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Terminated
Phase 2

Conditions

Unilateral Cleft Lip

Treatments

Biological: platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT02958306
SMohasin

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

3 to 6 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

platelet rich plasma
Experimental group
Description:
autologous blood product
Treatment:
Biological: platelet rich plasma
no platelet rich plasma
No Intervention group
Description:
control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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