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Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery

Sponsor
Deraya University (Other)
Overall Status
Completed
CT.gov ID
NCT05142072
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.1
Actual Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

One of this method's drawbacks is the healing of cauterized cartilage after processing. It was reported that the healing is so slow as no dosage form can reach this place in addition to the scares produced from healing is very irritable to the patient.

From this point, the investigators start searching for a solution to this problem and reach the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and efficacy of burn healing.

The dosage form of choice that was reported before for intranasal application by the same team of investigators and gave good results. the intranasal films were proved for its convince, simplicity, efficacy, and compliance to patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D3
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Formulation, Characterization and In-vivo Evaluation of Controlled Release Intranasal Films of Vitamin D3 as an Optimistic Dosage Form for Rapid and Effective Healing of Cauterized Turbinectomy
Actual Study Start Date :
Dec 18, 2021
Actual Primary Completion Date :
Jan 18, 2022
Actual Study Completion Date :
Feb 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: vitamin D film

Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon

Drug: Vitamin D3
intranasal film
Other Names:
  • Calciferol

    		•
    Other: control group

    No devices will be added

    Drug: Vitamin D3
    intranasal film
    Other Names:
  • Calciferol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Healing of cauterized tissues after surgery procedures [three week]

      The outcome will be measured by endoscopic scanning pre and after application of the drug in the dosage form (representing the percent of healing) by the ENT surgeon.

    Secondary Outcome Measures

    1. patients compliance from the new dosage form [three weeks]

      The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire

    2. Assessment of grades of healing by ENT surgeon [three weeks]

      Evaluation of (1) bleeding (amount and frequencies), (2) crustation ( amount and nature), and (3) inflammation (size and the redness of the place of surgery)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients complain of nasal obstruction

    • do not respond to medications

    • treatment need surgery

    • patients accept following up in a timely manner for 3 weeks

    Exclusion Criteria:

    • no nasal polyps,

    • have problems with the surgical procedures

    • have allergy with any of the treatment components (vitamin D3 or chitosan)

    • don't follow instructions or miss the following up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Minya university, faculty of medicin Minya المنيا Egypt 05673

    Sponsors and Collaborators

    • Deraya University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soad Ali, lecturer of pharmaceutics and clinical pharmacy Deraya university, Deraya University
    ClinicalTrials.gov Identifier:
    NCT05142072
    Other Study ID Numbers:
    • DNFs
    • Ahmed Ali
    First Posted:
    Dec 2, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Nasal Obstruction
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Mar 9, 2022