Fecal incontinence – a serious threat to patients

Additional patient suffering

In addition to the prevailing condition that brought them to the ICU, patients could have an undignified experience if FI is not taken care of effectively. Hospitalized adults with fecal incontinence are 22 times more likely to develop pressure ulcers than patients without fecal incontinence 2

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Increased cross-contamination risk

C. difficile is shed in feces and can be transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item3. In the USA, 1 in 5 patients with a healthcare-associated C. difficile infection experiences a recurrence of the infection 4

a person in a lab coat and mask using a computer

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A heavy burden for health systems & HCPs

FI negatively impacts the treatment outcome binding significant resources and leading to prolonged patient suffering. If FI is not managed effectively additional and non-reimbursable cost can skyrocket. C. difficile infections result in approximately 3 million cases of diarrhea and colitis in the United States each year 6.

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We make fecal management our priority, so it doesn’t have to be yours.

How does Flexi-Seal™ PROTECT PLUS aid fecal management?

Helps to reduce the risk of skin breakdown

Flexi-Seal™ helps to minimize the soiling of linens through diversion and containment of fecal matter

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Helps to prevent the spread of infection

Proven in vitro to contain the spread of C. difficile and prevent C. difficile from spreading into the environment 16 Containment and control of liquid or semi-liquid fecal matter may help to reduce the risk of dermatitis or perianal wound contamination. It may also end the spread of infection from soiling.

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Helps to improve patient care

Most importantly, Flexi-Seal™ PROTECT PLUS helps to maintain patient dignity.

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Helps to save nursing time

Flexi-Seal™ PROTECT PLUS is simple to use. With easily identifiable parts and improved features, it lessens the time involved in changing linens or cleaning the patient.

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Flexi-Seal™ PROTECT PLUS Instruction for use video (US version)

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Flexi-Seal™ PROTECT PLUS Instruction for use video

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Customer Testimonial: Flexi-Seal™ PROTECT PLUS

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Customer Testimonial: The Royal Liverpool Hospital, UK

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In vitro test: Removal force Flexi-Seal™ SIGNAL™ FMS

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Webinar: Optimizing fecal containment

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Flexi-Seal™ PROTECT PLUS PROTECT Indicator

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Flexi-Seal™ PROTECT PLUS Efficacy of stool containment

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Flexi-Seal™ PROTECT PLUS - User video, Germany

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Bayón García, Cristina & Binks, Rachel & De Luca, Enrico & Dierkes, Christine & Franci, Andrea & Gallart, Elisabet & Niederalt, Georg & Wyncoll, Duncan. (2012). Prevalence, management and clinical challenges associated with acute faecal incontinence in the ICU and critical care settings: The FIRSTTM cross-sectional descriptive survey. Intensive & critical care nursing : the official journal of the British Association of Critical Care Nurses. 28. 242-50.
Langill M, Yan S, Kommala D, et al. A Budget Impact Analysis Comparing use of a Modern Fecal Management System to Traditional Fecal Management Methods in Two Canadian Hospitals. Ostomy Wound Management 2012; 58(12)25-33.
CDC FAQ on C. difficile. Available at: http://www.cdc.gov/cdiff/index.html, Accessed 25th of October 2019
Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, et al. Burden of Clostridium difficile Infection in the United States. New England Journal of Medicine. 2015;372(9):825–34.
Schroeder MS. Clostridium difficile-associated diarrhea. Am Fam Physician. 2005;71(5);921-928.
Zhang S, Palazuelos-Munoz S, Balsells E M, Nair H, Kyaw M H. Cost of hospital management of Clostridium difficile infection in United States—a metaanalysis and modelling study. BMC Infect Dis. 2016; 16(1): 447.
Optimizing Fecal Containment Using Individualized Balloon Volumes; Catherine T. Milne APRN, MSN, BC-ANP, CWOCN1; Ann Durnal RN, BSN, CWOCN2; Mary Webb, RN, BSN, MA, CIC3, 1Connecticut Clinical Nursing Associates, LLC, Bristol, Connecticut; 2Ascension Carondelet St Mary’s Hospital, Tucson, Arizona;3San Mateo Medical Center, San Mateo, California
Jackson M, McKenney T, Drumm J, Merrick B, LeMaster T, VanGilder C. Pressure ulcer prevention in high-risk postoperative cardiovascular patients. Crit Care Nurse. 2011;31(4):44–53
MAUDE FDA Data Analysis – Accessed during January 2019 – Data on file, ConvaTec.
Lucado J, Gould C, Elixhauser A. Clostridium difficile infections (CDI) in hospital stays, 2009. HCUP Statistical Brief 124. Rockville, MD: Agency for Healthcare Research and Quality. Available at: http://www.hcup-us.ahrq.gov/reports/ statbriefs/sb124.pdf.
Metcalf et al. Contamination Risk During Fecal Management Device Removal: An In vitro, Simulated Clinical Use Study. Wound Manage Prev 2019; 65(3): 30–37.
Odor Barrier Testing. 130124-001. Data on file, ConvaTec Inc.
Flexi-Seal® Privacy Bag Filter Evaluation. 121412-001. Data on file, ConvaTec Inc.
Minimizing the spread of C. difficile spores from the release of gas. February 19, 2013. Data on file, ConvaTec Inc.
García B, Binks R, De Luca E, Dierkes C, Franci A, Gallart E, Niederalt G, Wyncoll D, Vaes P, Soderquist B, Gibot S. Expert recommendations for managing acute fecal incontinence with diarrhea in the intensive care unit. J Intensive Care Soc. 2013;14(Suppl 2):1-9.
Jones S, Towers V, Welsby S, et al. Clostridium difficile Containment Properties of a Fecal Management System: An In Vitro Investigation. Ostomy Wound Management 2011;57(10):38–49.