Clinical Trials Directory

Trials / Terminated

TerminatedNCT02765737

Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
MiMedx Group, Inc. · Industry
Sex
All
Age
12 Months – 70 Years
Healthy volunteers
Not accepted

Summary

Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring

Detailed description

Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring

Conditions

Interventions

TypeNameDescription
OTHERDehydrated Human Amnion/Chorion MembraneDehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
DEVICEMepilex Ag

Timeline

Start date
2016-04-01
Primary completion
2019-01-01
Completion
2019-01-01
First posted
2016-05-09
Last updated
2022-05-17

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02765737. Inclusion in this directory is not an endorsement.