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FISTULA SOLUTION® Devices

The information on this page is intended for healthcare professionals. Patient-specific information is available in the "Patients" section of this site. Patients should consult a healthcare professional regarding specific medical conditions and treatments.
Products described on this website (and associated product information), may not be available for sale in all markets as a result of local regulatory requirements. For information regarding product availability in your market, please contact your local Acelity/KCI representative here.

One-piece, compressible isolation devices to help contain and control effluent.

Help manage patients with enteric fistulas using the WOUND CROWN®, FISTULA FUNNEL® and ISOLATOR STRIP®:

  • Diverts effluent from wound site
  • Simple and easy to understand product application
  • One piece, compressible isolation device
  • Customizable to handle different sizes and number of fistulas

 

KCI is the exclusive distributor of the fistula isolation devices.

WOUND CROWN®, FISTULA FUNNEL® and ISOLATOR STRIP® are trademarks of Fistula Solution Corporation.

Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies. Healthcare providers should review the product User Manual, Safety Information and/or Instructions for Use prior to application.


  • Overview
  • How it Works
  • Indications & Applications
  • Evidence & Outcomes
  • Ordering

Overview

Isolating and Diverting Toxic Effluent May Help the Wound Heal


Managing patients with complex abdominal wounds can be a struggle. Particularly challenging are enteric or intestinal fistulas that drain into open abdominal wounds.

 

A published case series of patients treated with the Wound Crown® device found:


• Control of effluent is critical to protect the wound bed from the corrosive effects of bowel contents and to allow the surrounding wound bed to develop granulation tissue.
• Inability to control effluent often requires both specialized wound care personnel and prolonged inpatient hospitalization. 

Reference:  Heineman JT, MD, MPH, Garcia LJ, MD, FACS, Obst MA, RN, BSN, CCRN, CWOCN, et.al. Collapsible Enteroatmospheric Fistula Isolation Device: A Novel, Simple Solution to a Complex Problem; Journal of the American College of Surgeons; 2015.

The Wound Crown®  Fistula Funnel®  and Isolator Strip® 

 

Are intended for use to isolate and divert effluent from enteroatmospheric fistulas, enterocutaneous fistulas, or an ostomy close to an incision.

System Components & Accessories
380x380-woundCrown.pngWound Crown®380x380-Fistula-Devices.jpgFistula Funnel®380x380-isolator-strip-fistula.pngIsolator Strip®

How it Works

  • ABOUT
  • SPECIFICATIONS
  • MATERIALS FOR DOWNLOAD

FISTULA SOLUTION® Device

 

If you need to isolate a small intestinal fistula or an ileostomy, may use Wound Crown®:

  • General applications
  • Isolates and controls the effluent of enteric fistulas and ostomy stomas

If you need to isolate small sized fistulas or sidewall fistulas, may use Fistula Funnel®

  • Tapered design flexes to isolate sidewall fistulas
  • Sizeable to 1, 2, or 3 centimeter isolation area diameter

If you need to isolate large fistulas, a group of fistulas or a large or uniquely shaped wound bed areas, may use Isolator Strip®

 

  • Flexible strip designed to be shaped as needed for specific isolation applications
 

The FISTULA SOLUTION® Device Portfolio provides several off-the-shelf options to facilitate THE CONTROL OF EFFLUENT

 

  • Bellows structure for smooth collapse
  • Polymeric material can be easily cut and customized to accommodate contours and variations in fistula size
  • Flange accepts range of standard ostomy pouches
  • Soft material conforms to peri-fistula area
 
WOUND CROWN®
Height: 4.8cm (1.9 inches)
Outer Diameter/Length: 7.0cm (2.8 inches)
Inner Diameter/Channel width: 38mm (1.5 inches)
Shelf Life: 2 years
FISTULA FUNNEL®
Height: 6.0cm (2.4 inches)
Outer Diameter/Length: 9.2cm (3.6 inches)
Inner Diameter/Channel width:
30mm (1.2 inches)– widest bellows
Shelf Life: 2 years

IISOLATOR STRIP®
Height: 3.4cm (1.3 inches)

Outer Diameter/Length: 35.6cm (14 inches)

Inner Diameter/Channel width: 28mm (1.1 inches)

Shelf Life: 2 years

 

Disinfect Product per Institutional Protocol before use.

 

Product Information.

Indications & Applications

  • INDICATIONS
  • APPLICATIONS
Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies. Healthcare providers should review the product User Manual, Safety Information and/or Instructions for Use prior to application.

FISTULA SOLUTION® products ARE:
  • Stand alone devices intended to divert fistula effluent away from surrounding tissue

 

 

Instructions for Use

Clinical Solutions for

Applications
High output enteric fistula isolation using the Wound Crown®
1. Disinfect Wound Crown® per your institutional protocol.  Do not autoclave.  Cut a hole in the base of the Wound Crown® to create open skirt.  Trim skirt and bottom flange to best fit fistula or wound bed surface.
2. Cut 1.5 inch (3.8cm) hole in wound dressing that will center Wound Crown® over fistula or wound.
3. Insert Wound Crown® fully into hole until top flange is seated on top of wound dressing.  Ensure bottom flange is flush with bottom wound dressing and skirt extends below wound dressing.
4. Prepare wound bed.  Place assembled Wound Crown® and dressing onto wound bed so that Wound Crown® base is centered over fistula or wound. 
5. Seal entire dressing assembly with clear drape.  Cut drape from inner ring.  If seal is lost, try stoma paste inside Wound Crown® base.  Apply collection appliance to top flange.
APPLY NEW Wound Crown® WITH EACH DRESSING CHANGE
 
Large area enteric fistula isolation using the Isolator Strip®
1. Disinfect Isolator Strip® per your institutional protocol.   Do not autoclave. Locate bulb seal along bottom flange of device.  Bulb seal is designed to be placed DOWN on the wound bed.
2. Cut hole in wound dressing centered over fistula or wound.
3. Insert Isolator Strip® around perimeter of dressing hole until it overlaps itself.  Cut strip so that at least one full petal overlaps.  Ensure top flange is seated on top of wound dressing and bottom flange is flush with bottom of wound dressing. 
4. Prepare wound bed.  Place assembled Isolator Strip® and dressing onto wound bed so that Isolator Strip® opening is centered over fistula or wound.  
5. Seal entire dressing assembly with clear drape.  Cut drape from inner ring.  If seal is lost, try stoma paste inside Isolator Strip® base.  Apply collection appliance to top flange.
APPLY NEW Isolator Strip® WITH EACH DRESSING CHANGE
 
Small area enteric fistula isolation using the Fistula Funnel®
1. Disinfect Fistula Funnel® per your institutional protocol.  Do not autoclave.  Cut Fistula Funnel® to length to best fit wound depth and size.  Trim base skirt and bottom flange to best fit fistula or wound bed surface.  To create isolation area diameters of:
  • 1 cm – cut at base flange
  • 2cm – cut at center flange
  • 3 cm - use top opening
2. Cut 1 inch (2.5cm) hole in wound dressing that will center Fistula Funnel® over fistula or wound
3. Insert Fistula Funnel® fully into hole until top flange is seated on top of wound dressing.  Ensure bottom flange is flush with bottom of wound dressing and base skirt extends below wound dressings.
4. Prepare wound bed.  Place assembled Fistula Funnel® and dressing onto wound bed so that Fistula Funnel® base is centered over fistula or wound.
5. Seal entire dressing assembly with clear drape.  Cut drape from inner ring. If seal is lost, try stoma paste inside Fistula Funnel® base.  Apply collection appliance to top flange.
APPLY NEW Fistula Funnel® WITH EACH DRESSING CHANGE

 

Instructions for Use

Clinical Solutions for

Evidence & Outcomes


FISTULA SOLUTION® Devices have been shown in clinical studies to be associated with positive clinical
outcomes.


Reference:  Heineman JT, MD, MPH, Garcia LJ, MD, FACS, Obst MA, RN, BSN, CCRN, CWOCN, et.al. Collapsible Enteroatmospheric Fistula Isolation Device: A Novel, Simple Solution to a Complex Problem; Journal of the American College of Surgeons; 2015. 

Clinical Evidence

Additional summary of evidence and outcomes.
View Clinical Evidence
TITLE Collapsible Enteroatmospheric Fistula Isolation Device: A Novel Simple Solution to a Complex Problem.
View Abstract on PubMed
STUDY TYPE All levels
DATE 2015
AUTHORS Heineman, et al.
Ordering
 
To order any of the products listed below, please contact your KCI representative or call your local KCI Office. Click here to view our locations.

  • Product Codes

    PRODUCT                                                                                                 PRODUCT CODE                                   ORDERING OPTION
     
    380x380-woundCrown.png

    WOUND CROWN®

    		 Item #00860013000301   each 
     
      
    380x380-Fistula-Tunnel.png

    FISTULA FUNNEL®

    		 Item #00860013000325  each 

     
    FISTULA FUNNEL®

    ISOLATOR STRIP®

    		 Item #00860013000318  each 


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