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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D film<br>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<br>* intranasal film<br>* Other names: Calciferol;|
| Other: control group<br>No devices will be added | Drug: Vitamin D3<br>* intranasal film<br>* Other names: Calciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | three weeks | 
| 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) | three weeks |