Clinical trial

Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis

Name

SPASX020

Description

Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.

Trial arms

Trial start

2023-05-01

Estimated PCD

2023-09-30

Trial end

2023-12-31

Status

Completed

Treatment

StrataXRT

StrataXRT® is a TGA-approved silicone-based topical preparation. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation and when used as directed, dries to form an inert, thin, flexible wound dressing with a protective layer that is gas permeable and waterproof. It is the only self-drying topical silicone gel indicated for the use on radiation dermatitis, which hydrates and protects compromised skin areas and open wounds from chemical and microbial invasion. StrataXRT helps create an optimal wound healing environment which leads to faster re-epithelialization and a reduced inflammatory response. The product can be applied to fresh incisions and excisions, open wounds and compromised skin surfaces.

Arms:

StrataXRT

Calendula

Calendula creams are over-the-counter (OTC) skin care ointments that are non-greasy, non-sticky, and quickly absorbed by the skin. Calendula is a topical agent derived from a plant of the marigold family Calendula Officinalis and is used in cuts, scrapes, chafing and minor burns. Containing numerous polyphenolic antioxidants, calendula has been studied in both the laboratory and clinical setting for the use in treating and preventing radiation induced skin toxicity.

Arms:

Standard of care

Aquaphor

Aquaphor, containing 41 percent petrolatum (or petroleum jelly), temporarily protects minor cuts, scrapes, and burns; Aquaphor protects and helps relieve chapped or cracked skin and lips, as well as helps protecting from the drying effects of wind and cold weather.

Arms:

Standard of care

Size

344

Primary endpoint

CTCAE for Radiation Dermatitis

5 weeks

Eligibility criteria

Inclusion Criteria: * Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy * Fractionated courses including at least 30 fractions (treatments) * Minimum of 18 completed radiation treatments * Radiation dose: \> 50 Gy * Radiation technique: IMRT * Radiation equipment: TrueBeam or Tomotherapy Exclusion Criteria: * Prior radiation to the treatment area * Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis. * Patients undergoing SBRT * Patients with existing rashes or wounds in the target region or radiation therapy at RT start * Patients receiving hypofractionation * Patient receiving bolus

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 344, 'type': 'ACTUAL'}}

Updated at

2024-02-01

1 organization

2 products

1 indication

Organization

Product

Indication

Product