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

Early Phase 1

Completed

• Conditions: Nasal Obstruction
• Interventions: Drug: Vitamin D3

• Registration Number: NCT05142072
• Lead Sponsor: Deraya University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-02
• Study Start: 2021-12-18
• Primary Completion: 2022-01-18
• Study Completion: 2022-02-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Vitamin D3	No devices will be added
vitamin D film	Vitamin D3	Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon

Primary Outcome Measures

Name	Time	Method
Healing of cauterized tissues after surgery procedures	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 Outcome Measures

Name	Time	Method
Assessment of grades of healing by ENT surgeon	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)
patients compliance from the new dosage form	three weeks	The patient compliance will be measured by rating the pain and the development of symptoms before surgery using a questionnaire

Trial Locations

Locations (1)

Minya university, faculty of medicin; 🇪🇬 Minya, المنيا, Egypt