Clinical Trials Logo
  1. Home
  2. Wound
  3. NCT04621838

To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

Wound Clinical Trial

Official title:
To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing With Respect to Wound Exudate Management, Wound Healing Progression and Peri Wound Skin Condition.

Clinical Trial Summary

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.

Clinical Trial Description

This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04621838
Study type Interventional
Source Advanced Medical Solutions Ltd.
Contact
Status Completed
Phase N/A
Start date April 21, 2020
Completion date February 28, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT03674749 - The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds N/A
Completed NCT06464250 - The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients N/A
Completed NCT05297721 - Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study
Withdrawn NCT03909503 - A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds N/A
Recruiting NCT03386175 - Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound
Active, not recruiting NCT04701632 - Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool
Completed NCT05618496 - Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients N/A
Not yet recruiting NCT03640871 - HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer N/A
Completed NCT02399722 - Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone N/A
Completed NCT04507724 - The Use of Biochemical Analyzes to Monitor the Development of Wounds
Recruiting NCT05556954 - Diabetic Foot Ulcers Microbiome and Pathogen Identification
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Terminated NCT03723603 - An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds N/A
Completed NCT03754426 - A Prospective, Pilot Evaluation of Device Equivalence
Recruiting NCT02643680 - Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites Phase 2
Recruiting NCT01913132 - PICO Above Incisions After Vascular Surgery N/A
Recruiting NCT01347489 - Cronic Pressure Wounds and Relation With Gender N/A
Recruiting NCT04621825 - Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam N/A
Withdrawn NCT03723577 - An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds N/A