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Completed

NCT Number: NCT05142072

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

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.

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Minya university, faculty of medicin

Minya, Minya Governorate, 05673, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

intranasal film

Other names: Calciferol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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