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

NCT05142072 | Completed Early Phase 1

• 2 other identifiers: DNFsAhmed Ali
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• patients compliance from the new dosage form

  three weeks

• Assessment of grades of healing by ENT surgeon

  three weeks

Study Arms (2)

vitamin D film

EXPERIMENTAL

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

control group

OTHER

No devices will be added

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

intranasal film

Also known as: Calciferol

control group; vitamin D film

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients complain of nasal obstruction
• do not respond to medications
• treatment need surgery
• patients accept following up in a timely manner for 3 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Minya university, faculty of medicin

Minya, Minya Governorate, 05673, Egypt

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pharmaceutics and clinical pharmacy Deraya university

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 2, 2021
• Study Start: December 18, 2021
• Primary Completion: January 18, 2022
• Study Completion: February 20, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

EG (1)