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

March 8, 2022 updated by: Soad Ali, Deraya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • المنيا
      • Minya, المنيا, Egypt, 05673
        • Minya university, faculty of medicin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of cauterized tissues after surgery procedures
Time Frame: 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.
three week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients compliance from the new dosage form
Time Frame: three weeks
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
Time Frame: 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)
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2021

Primary Completion (ACTUAL)

January 18, 2022

Study Completion (ACTUAL)

February 20, 2022

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (ACTUAL)

December 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNFs
  • Ahmed Ali (OTHER: minia university faculty of medicine)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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