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

NCT ID: NCT05142072

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-18

Study Completion Date

2022-02-20

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.

Detailed Description

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Conditions

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Nasal Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

intranasal film

control group

No devices will be added

Group Type OTHER

Vitamin D3

Intervention Type DRUG

intranasal film

Interventions

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Vitamin D3

intranasal film

Intervention Type DRUG

Other Intervention Names

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Calciferol

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deraya University

OTHER

Sponsor Role lead

Responsible Party

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Soad Ali

lecturer of pharmaceutics and clinical pharmacy Deraya university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minya university, faculty of medicin

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ahmed Ali

Identifier Type: OTHER

Identifier Source: secondary_id

DNFs

Identifier Type: -

Identifier Source: org_study_id

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