Effects of hyperbaric oxygen therapy on resuscitating mucosal microcirculation and tissue repair in patients who received radiotherapy for malignant disease in the head and neck regio

Completed

• Conditions: bloedoorstroming in de microvaten; atrophy of the epithelium; decreased vascularity; obliterative endarteritis; 10019190; 10047079

• Registration Number: NL-OMON45130
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Patients referred to the Department of Hyperbaric Medicine in the AMC for treating osteoradionecrose and nonhealing ulcerations associated with a previous history of RT in the head and neck region.
• Patients referred to the Department of Hyperbaric Medicine in the AMC for HBOT prior to and after surgical intervention in the irradiated oral tissue.
• Patients >=18 years.
• Informed consent.

Exclusion Criteria

• Patients with oral surgery within the last month prior to the start of the investigation.
• Trismus that complicates sufficient mouth opening for measurements.
• Mucosa that is to painful for measurements.
• Patients <18 years.
• No signed informed consent.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Capillary enumeration (i.e. counting of the capillary loops present in each<br /><br>visual field). The average from 5 captured video frames will be computed and<br /><br>recorded to represent the capillary density at each time point in all patients.<br /><br>- We will make a close observation of the morphology. Given that we do not know<br /><br>what to expect, this will not be quantified other than noted descriptively<br /><br>afterwards. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>