# A Silicone-Based Film-Forming Gel Wound Dressing for Radiation Dermatitis in Head and Neck Cancer Patients: A Retrospective Cohort Analysis Using Clinical Informatics

## TL;DR

A silicone-based gel dressing reduced severe skin reactions in head and neck cancer patients undergoing radiation therapy compared to standard moisturizers.

## Contribution

A novel film-forming gel, StrataXRT, was shown to significantly reduce the risk of severe radiation dermatitis in head and neck cancer patients.

## Key findings

- StrataXRT reduced the risk of grade 2+ radiation dermatitis by 36.5% compared to standard moisturizers.
- The number needed to treat to prevent one case of severe dermatitis was seven patients.
- The absolute risk reduction was 14.5% in patients using StrataXRT.

## Abstract

Purpose

Patients undergoing radiotherapy for head and neck cancers often experience radiation dermatitis, which is typically managed by applying topical moisturizers. A silicone-based polymer film with antibacterial properties, StrataXRT, has been developed to mitigate radiation-induced side effects. We sought to determine the efficacy of StrataXRT compared with standard moisturizers in reducing the incidence of severe radiation dermatitis in patients with head and neck malignancies.

Materials and methods

We conducted a retrospective analysis of patients treated with StrataXRT compared with historical controls using conventional moisturizers (largely Aquaphor®) via a clinical informatics approach. Propensity score matching was used to control for dosimetric properties: mean skin dose, maximum skin dose, and the surface area receiving 40 Gy or higher. The endpoint was grade 2+ radiation dermatitis, measured using Common Terminology Criteria for Adverse Events or CTCAE, in 171 patients treated with StrataXRT, compared with 171 matched patients treated with a standard moisturizer. Multivariable Cox regression was performed to estimate the association between StrataXRT and standard moisturizer while adjusting for confounding clinical variables.

Results

In the multivariable Cox regression, the hazard ratio was 0.61 (95% CI (0.37, 1.0), p=0.049) with a relative reduction in the risk of grade 2+ radiation dermatitis of 36.5% with the use of StrataXRT compared with standard moisturizers. The absolute risk reduction with StrataXRT was 14.5%, which translates to a number needed to treat of seven patients to prevent one occurrence of grade 2+ radiation dermatitis.

Conclusions

Patients benefited from StrataXRT, with a significant reduction in the incidence of grade 2+ radiation dermatitis throughout the course of treatment. This study supports the adoption of a novel topical agent providing barrier protection in the form of a film-forming gel to reduce acute radiation dermatitis in head and neck cancer patients.