NCT05810194

Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: Stratpharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2023-04-12
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study