Clinical Trials Logo

Clinical Trial Summary

Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.

Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.


Clinical Trial Description

This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation.

A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects.

Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%.

The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent.

The subjects were participating in the study for 14 days postop. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02210208
Study type Interventional
Source Molnlycke Health Care AB
Contact
Status Completed
Phase N/A
Start date September 2014
Completion date June 15, 2016

See also
  Status Clinical Trial Phase
Withdrawn NCT02241941 - Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury Phase 4
Completed NCT05063409 - Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting N/A
Completed NCT03730688 - Non-invasive Limb Compartment Pressure Measurement N/A
Recruiting NCT04368117 - STAT: Standard Therapy Plus Active Therapy N/A
Terminated NCT01773083 - Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma Phase 3
Completed NCT02092701 - Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period N/A
Recruiting NCT06263296 - Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare N/A
Completed NCT02145130 - Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects Phase 1
Completed NCT01618630 - Amino Acid Supplementation in Recovery From Severe Burns N/A
Recruiting NCT05876442 - Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury N/A
Completed NCT04417439 - The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
Completed NCT02417779 - Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy N/A
Completed NCT02417818 - Cutaneous Microcirculation After Plasma Therapy N/A
Completed NCT02417805 - Cutaneous Microcirculation After Remote Ischemic Preconditioning N/A
Completed NCT01404026 - Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury N/A
Completed NCT03204669 - Trace Element Repletion Following Severe Burn Injury N/A
Recruiting NCT04947449 - Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors
Not yet recruiting NCT05532488 - Inulin in Burn-induced Insulin Resistance N/A
Recruiting NCT02189538 - Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients N/A
Completed NCT01795079 - Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury N/A