A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of

Status Completed

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

Clinical Trial Details

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

View Details

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Withdrawn	`NCT02241941` - Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury	Phase 4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	`NCT02417805` - Cutaneous Microcirculation After Remote Ischemic Preconditioning	N/A
Completed	`NCT02417818` - Cutaneous Microcirculation After Plasma Therapy	N/A
Completed	`NCT02417779` - Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy	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

A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. — MpTAg03

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms