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FISTULA SOLUTION® Devices

FISTULA SOLUTION® Devices
FISTULA SOLUTION® Devices
Wound Crown®
Wound Crown®
Isolator Strip®
Isolator Strip®
Fistula Funnel®
Fistula Funnel®

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
 
FISTULA SOLUTION, Wound Crown, Fistula Funnel and Isolator Strip are trademarks of Fistula Solution Corporation

Overview

Isolating and Diverting Toxic Effluent Can 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

How it Works

  • About
  • Specifications
  • Materials For Download

About

FISTULA SOLUTION® Devices

 

If you need to isolate a small intestinal fistula or an ileostomy, 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 , 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, use Isolator Strip®
 
  • Flexible strip designed to be shaped as needed for specific isolation applications

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

 
  • Bellows structure allows 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
 

Specifications

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: 7.6cm (3.0 inches)
Outer Diameter/Length: 9.2cm (3.6 inches)
Inner Diameter/Channel width:
30mm (1.2 inches)– widest bellows
10mm (0.4 inches ) – base
Shelf Life: 2 years
 
Isolator 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.
 

Materials For Download

Product Information

Indications & Applications

Indications & Applications

  • Indications
  • Applications

Indications for Use

FISTULA SOLUTION® products ARE:
• Stand alone devices intended to divert fistula effluent away from surrounding tissue
• To be used in conjunction with the wound management plan ordered by the clinician
• The wound management plan may include V.A.C.® Therapy or ABTHERA™ Open Abdomen Negative Pressure Therapy
 
 

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.
 

Clinical Evidence

Additional summary of evidence and outcomes.

Evidence & Outcomes

Supporting publications

Title Study Type Date Authors