A feasibility randomized controlled study of buccal fat pad, framycetin sulphate, and Trigona honey dressings in lateral defect palatoplastyt: Effect on WBC and VEGF levels
Tahapan Penelitian : Complete
Sponsor:
Financial support
Grant number: 02278/UN4.22.2/PT.01.01.2024
Mitra Pelaksana:
-
No Registry
Tanggal Input Registry : 23-08-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 16-08-2023 |
| Outcome Primer | Change in White Blood Cell (WBC) count and Vascular Endothelial Growth Factor (VEGF) level |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A feasibility randomized controlled study of buccal fat pad, framycetin sulphate, and Trigona honey dressings in lateral defect palatoplastyt: Effect on WBC and VEGF levels |
| Judul Penelitian Ilmiah | A feasibility randomized controlled study of buccal fat pad, framycetin sulphate, and Trigona honey dressings in lateral defect palatoplastyt: Effect on WBC and VEGF levels |
| Jenis Penelitian | Interventional |
| Intervensi | Study Arm 1 (Intervention A): Buccal fat pad (BFP) graft applied to lateral palatoplasty defect. Study Arm 2 (Intervention B): Sterile gauze dressing impregnated with framycetin sulfate solution, applied to lateral palatoplasty defect. Study Arm 3 (Intervention C): Sterile gauze dressing impregnated with Trigona honey, applied to lateral palatoplasty defect. |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Inclusion criteria included: (1) patients aged 1,5–6 years, (2) Good general health, without systemic diseases affecting wound healing, and (3) willingness to comply with follow-up visitsExclusion Criteria: Patient with a history of allergy to honey, antibiotics aminoglycosides and anesthetics, active infection at the surgical site, immunodeficiency, were excluded. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. UH 17120890 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | No. UH 17120890 |
| Contact Person | Abul - Fauzi |