Back to resultsDesign and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional supportive care trial for Nasal Obstruction
Eligibility Criteria
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
Sites / Locations
- Minya university, faculty of medicin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
vitamin D film
control group
Arm Description
Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon
No devices will be added
Outcomes
Primary Outcome Measures
Healing of cauterized tissues after surgery procedures
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
patients compliance from the new dosage form
The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire
Assessment of grades of healing by ENT surgeon
Evaluation of (1) bleeding (amount and frequencies), (2) crustation ( amount and nature), and (3) inflammation (size and the redness of the place of surgery)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05142072
Brief Title
Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2021 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deraya University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D film
Arm Type
Experimental
Arm Description
Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon
Arm Title
control group
Arm Type
Other
Arm Description
No devices will be added
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Calciferol
Intervention Description
intranasal film
Primary Outcome Measure Information:
Title
Healing of cauterized tissues after surgery procedures
Description
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.
Time Frame
three week
Secondary Outcome Measure Information:
Title
patients compliance from the new dosage form
Description
The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire
Time Frame
three weeks
Title
Assessment of grades of healing by ENT surgeon
Description
Evaluation of (1) bleeding (amount and frequencies), (2) crustation ( amount and nature), and (3) inflammation (size and the redness of the place of surgery)
Time Frame
three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Minya university, faculty of medicin
City
Minya
State/Province
المنيا
ZIP/Postal Code
05673
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery
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