Clinical Studies

Frequently Reviewed Studies

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Efficacy of a Novel Skin Antiseptic Against Carbapenem-resistant Enterobacteriaceae

Author(s): Timothy L. Wiemken, Robert R. Kelley, Ruth M. Carrico, Laura E. Binford, Brian E. Guinn, William A. Mattingly, and others

Source: American Journal of Infection Control Vol. 43 Issue 4 p380-382 February 5, 2015

DOC ID: 01

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Efficacy and Safety of a Novel Skin Cleansing Formulation Versus Chlorhexidine Gluconate

Author(s): Paulson DS, Topp R, Boykin RE, Schultz G, Yang Q.

American Journal of Infection Control, Vol 46, Issue 11, p1262-1265, June 5, 2018

DOC ID: H2H.3

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Evaluating the Effectiveness of a Multidimensional Bundle to Reduce Urinary Tract Infection in Long-term Care Spinal Cord Injury/Disordered Patients: A Retroactive Review

Author(s): Edward Hines Jr VA Hostpital. Chaiken N, Pazzaglia J, Polakkattil B, Tower-Woods W, Schwartz R, Lombardo

Source: R. Journal of Wound Ostomy & Continence Nursing, May 2020

DOC ID: CAUTI.11

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Beyond the Bundles: A Pilot to Evaluate a Silver Based Bathing Product to Reduce Central Line-Associated Bloodstream Infections

Author(s): Lisa Pinner, RN, MSN, CNS, CPON, BMTCN, Rachel Frisch, BSN, BMTCN, Jenna Kruger, MPH, CPHQ, and Lianna Marks, MD

Source: Lucile Packard Children’s Hospital (Stanford Health)

DOC ID: CLABSI.46

Institutional Clinical Studies: Event/Location

CAUTI/UTI (Catheter Acquired Urinary Tract Infection): Institutional Studies

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Innovative “EcInnovative “Eco-Friendly” Skin Care Formulation Reduces Nosocomial Associated CAUTI Rates When Used for Insertion and Maintenance of Urinary Catheter

Author(s): George A Turini III M.D, MSc., Joseph F. Renzulli II M.D.,

Source: Department of Urology – Section of Minimally Invasive Urologic Surgery

DOC ID: CAUTI.14

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Preventing Chronic Urinary Tract Infections From Urine and Fecal Incontinence: The Impact of Theraworx

Author(s): Jacque Whitley RN, Mariah Minor RN, Kate Loudon RN

Source: Peterson Healthcare, Peoria IL,

POSTER PRESENTATION

DOC ID: UTI.21

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Closing the Gap: Targeting CAUTIs with a Novel Approach to Perineal Care

Author(s): Hargett L, Anderson T.

Source: Journal of Critical Care Nursing, April 2020 – University of Maryland Medical System

DOC ID CAUTI 51

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Strategies to Prevent Urinary Tract Infection from Urinary Catheter Insertion in the Emergency Department

Author(s): Kimberly Parnell Burnett, MSN, Deborah Erickson, MSN, Ann Hunt, MSN, Lynn Beaulieu, MSN, Peggy Bobo, ADN, Penny Shute, BSN, MPH, Augusta, GA

Source: Journal of Emerg Nursing, 36(6) November 2010

DOC ID: CAUTI.17

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Can’t Attribute UTI TO Insertion: Utilizing Data to Prevent CAUTI

Author(s): Smith, N.C., Granich, M., Lien, H., Schipper, A. University of Washington Medical Center, Seattle, WA

Source: UW Medicine University of Washington Medical Center

DOC ID: CAUTI.49

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Equipping Clinicians with Advanced Care Options Leads to Reduction in UTI: Theraworx Works Wonders

Source: Meadowview Health and Rehab Center, AHCA Spring Session, 2017

POSTER PRESENTATION

DOC ID: UTI.23

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Evaluating the Effectiveness of a Multidimensional Bundle to Reduce Urinary Tract Infection in Long-term Care Spinal Cord Injury/Disordered Patients: A Retroactive Review

Source: Edward Hines Jr VA Hospital.

Author(s): Chaiken N, Pazzaglia J, Polakkattil B, Tower-Woods W, Schwartz R, Lombardo R.

Source: Journal of Wound Ostomy & Continence Nursing, May 2020

DOC ID: CAUTI.11

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One Year CAUTI Free A Multi- Disciplinary Team Approach to Reducing CAUTI in Pediatric Intensive Care Unit

Author(s): Jessica McClusky, MSN, RN, CPN, CIC Grand Rapids, Michigan

Source: Spectrum Health Helen Devos Children’s Hospital

DOC ID: CAUTI.47

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The Theraworx Silver First Protocol: Impact on CAUTIs

Author(s): Christine M. Tusoch, RN, BSN, CIC (1); Kimberly A. Kovacic, RN (1); Timothy L. Wiemken PhD, MPH, CIC (2); 1.  Euclid Hospital, Cleveland OH; 2. University of Louisville, Louisville, KY)

Source: Cleveland Clinic

DOC ID: CAUTI.48

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Targeting Zero: One Hospital’s Journey to Reduce CAUTI

Author(s): Roser L, Piercy EC, Altpeter, T.

Source: Journ. Of Nurs Mgt 18-20 Dec 2014

DOC ID: CAUTI.24

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Effects of Education and Improved Foley Catheter Care on Nurse’s Knowledge and CAUTI

Author(s): Walters G, Lee J, Riddle L

Source: First Health of the Carolinas

POSTER PRESENTATION

DOC ID: CAUTI.20

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Theraworx Skin Care Formulation Reduces Nosocomial Associated CAUTI Rates When Used For Urinary Catheter Insertion and Maintenance

Author(s): Renzulli, J

Source: Journal of Clinical and Medical Investigation. Vol 2(2): 1-3

DOC ID: CAUTI.15

CLABSI (Central Line Blood Stream Infection): Institutional Studies

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CLABSI Reduction Seen with Multifactorial Nurse Initiative

Author(s): John Muir Health, CA

Source: ANCC Magnet Association, Fall Session, 2017

POSTER PRESENTATION

DOC ID: CLABSI.18

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Beyond the Bundles: A Pilot to Evaluate a Silver Based Bathing Product to Reduce Central Line-Associated Bloodstream Infections

Author(s): Lisa Pinner, RN, MSN, CNS, CPON, BMTCN, Rachel Frisch, BSN, BMTCN, Jenna Kruger, MPH, CPHQ, and Lianna Marks, MD

Source: Lucile Packard Children’s Hospital (Stanford Health)

DOC ID: CLABSI.46

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Journal of Critical Care Nursing: Change has arrived: antimicrobial bathing and CLABSI

Author(s): Sung P, Virgallito M, Murphy T, Boghossian R, Young R.

Source: Journal of Critical Care Nursing, April 2020

Source: USC Verdugo Hills Hospital

DOC ID: CLABSI.9

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Journal of Pediatric Oncology Nursing: Effectiveness of bath wipes after hematopoietic cell transplantation: a randomized trial

Source: St Jude Children’s Hospital

Author(s): Margie K, Qudeimat A, Browne E, Keerthi D, Sunkara A, Kang G, et al.

Source: Journal of Pediatric Oncology Nursing, 2020

DOC ID: CLABSI.8

Clostridium Difficile (CDI): Institutional Studies

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Preventing Hospital Acquired Clostridium Difficile Infection in ICU Patients: the Efficacy of Theraworx, a Novel Silver-based Cleanser

Source: Northwell Health – Peconic Bay Medical Center

Author(s): T. Dhansew DO, M. Masih MD, P. Paunikar MD, MPH, P. Mupo RN, BSN, H. Fischer RN, BSN

Source: Academic Competition and Research Symposium, 06/2020

DOC ID: CDI.13

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Reducing the Incidence of Clostridium Difficile Infections, Antibiotics and Costs in a Long-Term Care Setting–A Surveillance Experience

Author(s): Susan M Johnston, BSN, CIC

Source: Levindale Lifebridge Health Center

DOC ID: CDI.50

Children’s Hospitals Studies

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Beyond the Bundles: A Pilot to Evaluate a Silver Based Bathing Product to Reduce Central Line-Associated Bloodstream Infections

Author(s): Lisa Pinner, RN, MSN, CNS, CPON, BMTCN, Rachel Frisch, BSN, BMTCN, Jenna Kruger, MPH, CPHQ, and Lianna Marks, MD

Source: Lucile Packard Children’s Hospital (Stanford Health)

DOC ID: CLABSI.46

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One Year CAUTI Free A Multi-Disciplinary Team Approach to Reducing CAUTI in Pediatric Intensive Care Unit

Author(s): Jessica McClusky, MSN, RN, CPN, CIC

Source: Helen Devos Children’s Hospital, Grand Rapids, Michigan

DOC ID: CAUTI.47

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Effectiveness of Bath Wipes After Hematopoietic Cell Transplantation: A Randomized Trial

Source: St Jude Children’s Hospital

Author(s): Margie K, Qudeimat A, Browne E, Keerthi D, Sunkara A, Kang G, et al.

Source: Journal of Pediatric Oncology Nursing, 2020

DOC ID: CLABSI.8

Alternate Site Studies

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Preventing Chronic Urinary Tract Infections From Urine and Fecal Incontinence: The Impact of Theraworx

Author(s): Jacque Whitley RN, Mariah Minor RN, Kate Loudon RN

Source: Peterson Healthcare, Peoria IL

POSTER PRESENTATION

DOC ID: UTI.21

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Equipping Clinicians with Advanced Care Options Leads to Reduction in UTI: Theraworx Works Wonders

Source: Meadowview Health and Rehab Center

Source: AHCA Spring Session, 2017

POSTER PRESENTATION
DOC ID: UTI.23

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Successful Healing of IAD When Traditional Barriers Fail Using an Innovative Topical Formulation

Author(s): Diana Gallagher MS, RN, CWOCN, CFCN, Janalynn Miller FNP-C, GNP, CWCN-AP

Source: Symposium for Advanced Wound Care Fall 2018

POSTER PRESENTATION
DOC ID: WC.29

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Historical Comparison of Soft-tissue Infections in a Division 1 Wrestling Team After Adoption of a Novel pH Barrier Product

Source: Duke University

Author(s): Shaheen S, Bytomski J, Demyonovich D.

Source: The Journal of Sports Medicine and Physical Fitness, May 2018

DOC ID: AS.16

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Topical Innovation Used in the Treatment of More Than 4-Million ICU Patients in the Prevention of Hospital Acquired Infections Now Proven to Reduce the Incidence of Infections During Special Operations Training

Source: Camp MacKall

Author(s): Renzulli J, Pollock G, Strayer S, Lombardo R.

Source: Journal of Military Medicine, September 2020.

DOC ID: AS.26

Organisms, Wound & Skin

Organism Efficacy Studies

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Microbial Test Results: Microbial Testing Executive Summary

Author(s): Timothy L. Wiemken, Robert R. Kelley, Ruth M. Carrico, Laura E. Binford, Brian E. Guinn, William A. Mattingly, and others

Source: Microbiological Consultants, Apptec Laboratories, St. John’s Research Institute

DOC ID: O.40

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Efficacy of a Novel Skin Antiseptic Against Carbapenem-Resistant Enterobacteriaceae

Author(s):Timothy L. Wiemken, Robert R. Kelley, Ruth M. Carrico, Laura E. Binford, Brian E. Guinn, William A. Mattingly, and others

Source: American Journ of Infection Control, Vol. 43 Issue 4 p380–382. Published Online February 5, 2015

DOC ID: O.1

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Efficacy and Safety of a Novel Skin Cleansing Formulation Versus Chlorhexidine Gluconate

Author(s): Paulson DS, Topp R, Boykin RE, Schultz G, Yang Q

Source: R. Journal of Wound Ostomy & Continence Nursing, May 2020

DOC ID: H2H.3

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Duration of Action of Theraworx Against Methicillin-resistant Staphylococcus Aureus Utilizing an Innoculated Collagen Model

Author(s): Huckfeldt R.

Source: St. John’s Medical Research Institute

DOC ID: O.7

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Antimicrobial Effectiveness of Rinse-free Hospital Bathing Cleansers After 24hr of Initial Exposure to Common Pathogenic Micro-Organisms

Author(s): Olivi J, Austin CL, Thompson SJ

Source: Journal of Patient Care, 2018

DOC ID: O.4

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Theraworx V. Chlorhexidine Gluconate Bathing and Peri-Operative Skin Cleansing Study. St. John’s Research Center

Author(s): Huckfeldt R, et al

Source: St. John’s Research Center

CONTROLLED COMPARATIVE STUDY

DOC ID: H2H.6

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Another Tool in the Toolbox: A Novel, Multimodal, Surfactant-based Skin Cleanser vs. 62% Ethanol on the Human Coronavirus OC43 on Human Tissue

Author(s): Paulson DS

Source: Journal of Clinical and Medical Investigations, October 2020

DOC ID: 01

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Activity of a Novel, Multimodal, Surfactant-based Skin Cleanser on Coronaviruses, In-vitro

Author(s): Paulson DS

Source: Clinical and Medical Investigations ISSN:2398-5763

DOC ID: O.2

Wound And Skin Integrity Studies

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Effect of an Innovative pH Lowering Wound Therapeutic on MMP Levels and Bacterial Biofilm Colonization of Chronic Non-healing Wounds

Author(s): Marston W, Schultz G.

Source: Symposium on Advanced Wound Care, Fall 2018

POSTER PRESENTATION

DOC ID: WC.27

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Effect of an Innovative pH Lowering Wound Therapeutic on MMP Levels and Bacterial Biofilm Colonization of Chronic Non-healing Wounds

Author(s): William Marston, Gregory Schultz, Zachary Gortler, Kurt Schultz, Soo Jung Seo, Daniel Gibson, Haley Engelken

Source: Symposium on Advanced Wound Care, Fall 2019

POSTER PRESENTATION

DOC ID: WC.31

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Harnessing the Microbiome to Rapidly Resolve Peristomal Skin Complications

Author(s): Gallagher D, Juergens J.

Source: Symposium on Advanced Wound Care, Spring 2019

POSTER PRESENTATION

DOC ID: WC.28

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Successful Healing of IAD When Traditional Barriers Fail Using an Innovative Topical Formulation

Author(s): Gallagher D, Miller J.

Source: Symposium on Advanced Wound Care, Fall 2018

POSTER PRESENTATION

DOC ID: WC.29

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Non-toxic Skin Formulation Promotes Healing of Dermatitis and Skin Injuries that are Prone to Infection in Long-term Care Facility Residents

Author(s): Miller J, Renzulli J.

Source: F. Annals of Infectious Disease and Epidemiology, November 2016

DOC ID: WC.30

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Novel Skin Care System Helps in Healing Skin Wounds and Other Problematic Skin Disorders in Patients at Long-term Care Facilities

Author(s): Janalynn Miller FNP-C, GNP, CWCN-AP

Source: W.O.W. Case series (Wild on Wounds) National Conf Fall session 2016

DOC ID: WC.32

Clinical Data Brochure

Reference Documents

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The Skin Barrier as an Innate Immune Element

Author(s): Elias PM. Semin

Source: Immunopath (2007) 29:3-14

DOC ID: R.1

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Endorsement Letter and Information on Testing Results

Author(s): Dr. Peter Elias, UCSF

DOC ID: R.2

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The How, Why, and Clinical Importance of Stratum Corneum Acidification

Author(s): Elias, PE

Source: Experimental Dermatology Journ March 2017

DOC ID: R.3

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pH Directly Regulates Permeability Barrier Homeostasis and Stratum Corneum Cohesion/Integrity

Author(s): Hachem JP, et.al.

Source: Journ Invest Dematol, August 2003, issue: 121(12), p: 345-53

DOC ID: R.4

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CHG FDA Approval

DOC ID: R.8

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