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Novel Multivalent Wound-Healing Ointment Provides Bioburden Control and Moisture Management

A Retrospective Registry Data Analysis

Serena, Thomas MD, FACS; Connell, Heather BS, CCRP; McConnell, Sharon MS, CCRP; Patel, Keyur DO; Doner, Bryan DO; Sabo, Matthew DPM, FACFAS; Miller, Michael DO; Serena, Laura MEd, LPN; Le, Lam T. MD; Goldsmith, David BS; Chung, Jane BS

doi: 10.1097/01.ASW.0000490193.96840.9e
FEATURES: CASE SERIES
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OBJECTIVE: The purpose of this retrospective registry data analysis was to explore the effectiveness of a novel multivalent topical ointment (Terrasil Infection Control Wound Care Ointment; Aspiera Medical, Woonsocket, Rhode Island), containing a patented mineral complex and 0.2% benzethonium chloride in the treatment of nonhealing acute and chronic wounds.

DESIGN: Aspiera Medical designed a registry to capture physician experiences and treatment results with Terrasil Infection Control Wound Care Ointment. Physicians were asked to enter deidentified patient data into an online registry.

SETTING: Wound clinics in the United States were asked to participate in the registry.

PATIENTS: Physicians at 4 wound clinics treated 30 patients (26 of whom completed the treatment) with various chronic wounds that had persisted for an average of 6 months and entered treatment data into the registry.

INTERVENTIONS: Patients applied the ointment according to physician orders. Concurrent treatments used by patients included offloading, compression wraps, and dressings, such as collagen and calcium alginate. Patients were treated until complete wound closure or lost to follow-up.

MAIN OUTCOME MEASURES: Physicians calculated each patient’s percentage wound reduction at each visit.

MAIN RESULTS: Thirty patients were entered into the registry. Pretreatment and posttreatment measurements were available for 26 of them. Patients achieved an average surface area reduction of 84% in a mean of 23 days’ treatment.

CONCLUSION: The antimicrobial and moisturizing ointment studied appears to be effective in promoting wound closure in a variety of acute and chronic wounds. Wounds studied included diabetic foot ulcers, venous leg ulcers, venous stasis ulcers, surgical infections, burns, and insect bites. The results of this registry data analysis will be used to inform planned clinical trials.

Thomas Serena, MD, FACS, is Chief Executive Officer and Medical Director, SerenaGroup, Cambridge, Massachusetts. Heather Connell, BS, CCRP, is Clinical Research Manager, SerenaGroup, Pittsburgh, Pennsylvania. Sharon McConnell, MS, CCRP, is Director of Research, SerenaGroup, Pittsburgh, Pennsylvania. Keyur Patel, DO, and Bryan Doner, DO, are Co–Medical Directors; and Matthew Sabo, DPM, FACFAS, is Associate Director of Research/Staff Physician, The Wound Healing and Hyperbaric Center, ACMH, Kittanning, Pennsylvania. Michael Miller, DO, is Chief Executive Officer and Medical Director, Miller Care Group, Indianapolis, Indiana. Laura Serena, MEd, LPN, is Co-Safety Director, The Wound Healing and Hyperbaric Center, ACMH, Kittanning, Pennsylvania; and is Program Manager, SerenaGroup, Pittsburgh, Pennsylvania. Lam T. Le, MD, is Medical Director, St John Wound Center, Tulsa, Oklahoma. David Goldsmith, BS, is Director, Aspiera Medical, Woonsocket, Rhode Island. Jane Chung, BS, is a Medical Student, Dean’s Summer Research Program—Georgia Regents University/University of Georgia Medical Partnership, Athens, Georgia.

The authors have disclosed that Aspiera Medical, a division of Aidance Scientific, provided an unrestricted grant to help fund this case series. Dr Serena has disclosed that he is/was a consultant to MiMedix, NuoTherapeutics, EnzySurge, Angelini Pharma, Celleration, MediWound, RedDress, Sanuwave, Scioderm, Systagenix, Tissue Therapeutics, and KCI; has received grants from Smith & Nephew and KCI; is a member of the speakers’ bureau for KCI; and has received payment from KCI for educational presentations. Dr Miller has disclosed that he has received grant funding from ManukaMed, Calgon Carbon, and Crawford Healthcare; is/was a consultant to M-Med, Genadyne, Pensar Medical; and has received reimbursement for travel/meeting expenses unrelated to this article from the Wound Care Education Institute. Ms Connell and Drs Patel, Doner, Sabo, and Le, and Ms Serena, Ms McConnell, and Ms Chung have disclosed that they have no financial relationships related to this article. Mr Goldsmith has disclosed that he is employed as Director of Aspiera Medical.

Acknowledgment: The authors of this article received editorial assistance from John Jesitus, a Denver-based healthcare writer and editor, in preparing this manuscript. Submitted May 6, 2014; accepted in revised form January 26, 2015.

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