MedTrace Logo

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

NCT05614557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Wound Healing

Interventions

DEVICE

Stratacel

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

DEVICE

Stratamed

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

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • Stratpharma AG

    lead INDUSTRY

Principal Investigators

  • Hans J. Laubauch, Dr. med. · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614557 on ClinicalTrials.gov