Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04593914

A Novel Skin Barrier Protectant for Acute Radiodermatitis

Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Jessa Hospital · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

Conditions

Interventions

TypeNameDescription
DEVICECavilon Advanced Skin Protectant3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.

Timeline

Start date
2020-09-01
Primary completion
2021-09-01
Completion
2021-10-01
First posted
2020-10-20
Last updated
2021-11-03

Locations

2 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04593914. Inclusion in this directory is not an endorsement.