Health Trials

Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate

ConditionsCleft PalateUnilateral Cleft PalateBilateral Cleft PalateComplete Cleft PalatIncompelet Cleft Palate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorAl-Thawra Modern General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Standard palatoplasty ( control)

    Procedure/Surgery

    Conventional palatoplasty performed without biological adjuncts

  • Platelet _ Rich Fibrin ( PRF)

    Procedure/Surgery

    Conventional palatoplasty augmented with autologous PRF matrix

  • gentamicin_ loaded PRF

    Combination product

    Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Standard palatoplasty ( control )Active comparator 1 intervention
Group B: Standard palatoplasty + PRFExperimental treatment 1 intervention
Group C: Standard palatoplasty +Gentamicin- PRFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 7 day , 14 day , and 30 day postoperatively
2

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

Time frame
at 3 month postoperatively
3

wound healing score

Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.

Time frame
At 7 day , 14 day , and 30 day postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Thawra Modern General Hospital

Lead sponsor

Source ClinicalTrials.gov
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