NCT02958306

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

November 3, 2016

Last Update Submit

February 24, 2019

Conditions

Unilateral Cleft Lip

Keywords

cleft lip repaircheiloplastyPRPplatelet rich plasma

Outcome Measures

Primary Outcomes (2)

  • scar width

    scar width through orbicularis oris muscle by ultrasonography

    6 months

  • scar width

    scar width at skin surface via photograph

    6months

Secondary Outcomes (1)

  • vancouver scar scale

    6 months

Other Outcomes (1)

  • Philtral ridge length symmetry index

    6months

Study Arms (2)

platelet rich plasma

EXPERIMENTAL

autologous blood product

Biological: platelet rich plasma

no platelet rich plasma

NO INTERVENTION

control

Interventions

platelet rich plasmaBIOLOGICAL

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

Also known as: PRP
platelet rich plasma

Eligibility Criteria

Age3 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Egypt

Location

Study Officials

  • basma G mousa, professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 8, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

EG(1)