Unilateral Cleft LipPhase 2NCT02958306
Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair
A Phase 2 study testing platelet rich plasma in people with Unilateral Cleft Lip, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.
Read the 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.
- Conditions
- Unilateral Cleft Lip
- Being tested
- platelet rich plasma
- Keywords
- cleft lip repair, cheiloplasty, PRP, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaBiological
Also called PRP
PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma | Experimental | autologous blood product Receives: Biological: platelet rich plasma |
| no platelet rich plasma | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar width
scar width through orbicularis oris muscle by ultrasonography
Measured: 6 months
scar width
scar width at skin surface via photograph
Measured: 6months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cleft LipStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University
- Responsible party
- Principal investigator, Shaimaa Mohsen, Cairo University
- Investigators
- basma G mousa, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958306
- Sponsor's protocol ID
- SMohasin
- Status last verified
- Feb 2019
- First submitted
- 3 Nov 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02958306
- Acronym / sponsor ID
- SMohasin
- Conditions
- Unilateral Cleft Lip
- Keywords
- cleft lip repair, cheiloplasty, PRP, platelet rich plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Fayoum University
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma | Experimental | Biological: platelet rich plasmaautologous blood product |
| no platelet rich plasma | No intervention | –control |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with syndromic cleft lip
- Secondary lip treatment (previous operated cases)
- Bilateral cleft lip
- Patient older than six months
- Associated Cardiac anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaAlso: PRPPRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values | Biological | platelet rich plasma |
Primary outcome
scar width
Time frame: 6 months
scar width through orbicularis oris muscle by ultrasonography
scar width
Time frame: 6months
scar width at skin surface via photograph
1 secondary outcome
vancouver scar scale
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Unilateral Cleft Lip
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Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery
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MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Cleft Palate, Cleft Palate, Unilateral, Complete
RecruitingObservational study
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Cleft Lip and Cleft Palate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
basma G mousa, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing platelet rich plasma in people with Unilateral Cleft Lip, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar width (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.