CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Stratacel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05614557
NCT05614557N/ACompleted

Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions

Stratpharma AG·interventional·Posted Nov 14, 2022·Updated Sep 6, 2023

In Brief

A clinical study evaluating Stratacel and Stratamed for Wound Healing. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Delayed wound healing is considered a health problem with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, many other groups, as well as ourselves, have evaluated various alternatives to improve wound healing. Despite this, the scientific evidence demonstrating the efficacy of recently developed treatments is often limited. Stratacel® and Stratamed® are two gels approved by Swissmedic and the FDA for use in improving wound healing. To this end, the efficacy of these formulations has been visually tested by a physician or by patients. Using the most advanced medical technologies (confocal microscopy and LCOCT), this study aims to investigate the effect of these formulations on the healing of human skin. For this research, a total of 20 volunteers will be included in this study. Volunteers will have up to 7 follow-up appointments over 21 days. Each appointment will last approximately 30 minutes and will be used to perform external measurements of skin healing. All volunteers will use the same formulations (Stratacel® and Stratamed®) with the only difference between volunteers being the anatomical area of application of the formulation. This will be determined by chance. The active participation of the participant is requested for the application of the formulations on the skin twice a day during the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Healing
CountriesSwitzerland

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartMar 21, 2023
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.6 years ago

Interventions

Strataceldevice

Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).

Stratameddevice

Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).