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Investigating the effect of using hydroxyapatite mesh on the occurrence of fistula in patients undergoing primary palatoplasty by the Sommerlad intravelar veloplasty method

Investigating the effect of using hydroxyapatite mesh on the occurrence of fistula in patients undergoing primary palatoplasty by the Sommerlad intravelar veloplasty method

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240128060826N1
Enrollment
64
Registered
2024-02-13
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft palate. Cleft palate

Interventions

Intervention 1: Intervention group: In the patients of the intervention group, in addition to the routine care and surgical procedures that will be performed, a hydroxyapatite mesh (manufactured by Ha

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: Written informed consent from the patient's legal guardian to participate in the study Definitive diagnosis of cleft palate Surgery performed by a common surgeon Performing primary palatoplasty surgery using the intravelar veloplasty method and using a microscope

Exclusion criteria

Exclusion criteria: Presence of surgical site infections Unwillingness of the patient's guardian

Design outcomes

Primary

MeasureTime frame
Occurrence of fistula. Timepoint: 3 and 6 months after surgery. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Abdali

Esfahan University of Medical Sciences

abdali@med.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026