A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns

Date Added
July 6th, 2021
PRO Number
Pro00109484
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

Exploring the Burn Wound Microbiome Using Next Generation Sequencing Technology

Date Added
April 4th, 2023
PRO Number
Pro00123277
Researcher
Deepak Ozhathil

List of Studies

Keywords
Surgery
Summary

Exploring the Burn Wound Microbiome Using Next Generation Sequencing Technology study is designed to learn more about the microorganisms (bacteria and fungi such as yeast) that are present in traumatic burn wounds. We wish to learn how the make up of microbes differ between the wounded and uninjured skin. Currently, if a doctor wants to know which organisms exist in a burn wound, they would need to send a sample of the wound surface to be grown on a petri dish. Ultimately this system takes too long and may not identify all the organisms that may affect wound healing and as a result this method is no longer used for most burn wounds at most burn centers. Our study proposes to bridge this knowledge gap by using newly available techniques collectively referred to as "Next Generation Sequencing technology" or NGS for short. NGS has the potential to provide more detailed and accurate information about the make up of the burn wound and has already been used as a tool in other parts of healthcare. The information gained from this study may potentially improve the care of future burn patients.

Institution
MUSC
Recruitment Contact
Deepak Ozhathil
5086548246
ozhathil@musc.edu

Abbott Ventricular Tachycardia Post Approval Study

Date Added
October 24th, 2023
PRO Number
Pro00132390
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular
Summary

This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu



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