Cleft PalateNCT07752849
Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate
A study testing Platelet _ Rich Fibrin ( PRF) and gentamicin_ loaded PRF in people with Cleft Palate and Unilateral Cleft Palate, run by Al-Thawra Modern General Hospital at 1 site in Yemen.
Trial summary
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate
- What is being tested?
- Platelet _ Rich Fibrin ( PRF) and gentamicin_ loaded PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteYemen
- Study dates
- 1 Aug 2026to Dec 2028
- Phase
- Interventional
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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate.
- Scheduled for primary palatoplasty.
- Age within the specified study range.
- Informed consent signed by parents or legal guardians.
Who cannot join
- Patients with associated syndromic clefts or major congenital anomalies.
- Previous history of palatal surgery or failed prior palatoplasty.
- Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia.
- Patients lost to follow-up or incomplete records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Al_ Thawra General Hospital Authority
Sanaa
SUMYAH Mohammed Abdulwasea, MSc Trainee, +967730129165, deman9038@gamil.com
About this study
Official title: A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
- Conditions
- Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate
- Being tested
- Standard palatoplasty ( control), Platelet _ Rich Fibrin ( PRF), gentamicin_ loaded PRF
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard palatoplasty ( control)Procedure or surgery
Conventional palatoplasty performed without biological adjuncts
Platelet _ Rich Fibrin ( PRF)Procedure or surgery
Conventional palatoplasty augmented with autologous PRF matrix
gentamicin_ loaded PRFCombination product
Conventional palatoplasty augmented with gentamicin _ loaded PRF matrix
| Study group | Role | What they receive |
|---|---|---|
| Standard palatoplasty ( control ) | Active comparator | Conventional palatoplasty without biological adjuncts Receives: Procedure: Standard palatoplasty ( control) |
| Standard palatoplasty + PRF | Experimental | Conventional palatoplasty augmented PRF Receives: Procedure: Platelet _ Rich Fibrin ( PRF) |
| Standard palatoplasty +Gentamicin- PRF | Experimental | Conventional palatoplasty augmented with gentamicine - loaded PRF Receives: Combination Product: gentamicin_ loaded PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dehiscence rate
Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.
Measured: At 7 day , 14 day , and 30 day postoperatively
palatal fistula formation rate
Assessed using Oronasal Fistula Severity \& Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect > 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes
Measured: at 3 month postoperatively
wound healing score
Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.
Measured: At 7 day , 14 day , and 30 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Thawra Modern General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumyah Mohammed Abdulwasea Saeed, Al-Thawra Modern General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752849
- Sponsor's protocol ID
- CLEFT_PRF_2026
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No