Required Materials - Cook Medical Biodesign Mode D'emploi

USE OF ANTIMICROBIALS
Because the plug is used in surgical fields where sterility cannot be assured,
the use of antimicrobials is common practice and may prevent infectious
complications.
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the patient have been used successfully, and the U.S. Centers for Disease Control
recommends bowel cleansing and administration of prophylactic enteric and
intravenous antimicrobial agents before elective colorectal operations.
reference for specific dose, timing, and drug choices.)
Typical gastrointestinal flora can be expected to include a variety of
aerobic and anaerobic organisms. Therefore the following points should be
considered:
• Antimicrobials, if used topically or systemically, should provide coverage
against a wide spectrum of aerobic and anaerobic organisms.
• Mechanically prepare the colon by appropriate use of enemas and
cathartic agents.
• A dose of prophylactic antimicrobial agent should be given intravenously
and timed such that a bactericidal concentration of the drug is established
in serum and tissues when the device is implanted.
• Maintain therapeutic levels of the agent in serum and tissues throughout
the operation.
The presence of certain antimicrobials may inhibit revascularization and/or
infiltration of cells into the plug.
hinder neovascularization, epithelialization, and keratinocyte growth,
povidone iodine,
reported to slow or inhibit wound healing. Careful consideration is required
before using any antimicrobial or antiseptic (topical or systemic) that has
not been proven compatible with surgical implantation and wound healing.
However, no studies have been conducted to evaluate the combination of
antimicrobials with plug placement.
INSTRUCTIONS FOR USE
These recommendations are designed to serve only as a general guideline.
They are not intended to supersede the institutional protocols or professional
clinical judgment concerning patient care.
NOTE: Always handle the plug using aseptic technique, minimizing contact
with latex gloves.

REQUIRED MATERIALS

• A sterile dish (kidney dish or other bowl)
• Rehydration fluid: room temperature sterile saline or sterile lactated
Ringer's solution.
• Suitable resorbable suture, such as: 0 chromic, 2-0 or 0 coated polyglycolic
acid suture (coated PGA).
• 10cc syringe
• A short 14ga or 16ga catheter
• Saline or hydrogen peroxide for flushing
PREPARATORY
1. Remove the packaging containing the plug from the box.
2. Remove the inner pouch containing the plug from the outer package
using aseptic technique. Place the inner pouch in the sterile field.
3. Using sterile gloved hands, open the inner pouch carefully, and
aseptically remove the plug with a sterile instrument. Place the plug into
the sterile dish in the sterile field.
4. Add enough rehydration fluid to the dish to fully submerge the plug.
Allow the plug to rehydrate, fully submerged, until the desired handling
characteristics are achieved, but do not allow the plug to rehydrate any
longer than 2 minutes.
5. Attach a suitable resorbable suture (approximately 30 cm in length)
around the tail (narrow end) of the plug for pulling it into the fistula tract.
6. Prepare the patient and surgical site using standard surgical techniques
appropriate for anal fistula repair.
NOTE: The recommended practice for preoperative bowel preparation
in elective colorectal surgery includes mechanical bowel cleansing
through the use of enemas and cathartic agents, and administration of
prophylactic antimicrobial agents, oral or intravenous. Insufficient cleansing
or inadequate antibacterial prophylaxis can predispose the patient to
infections.
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PROCEDURAL
1. Perform under local, regional, or general anesthesia.
2. If a seton is not already in place, identify the internal (primary) fistula
opening by inserting a sterile probe into the external (secondary)
opening and navigating it through the fistula tract. Alternatively, injection
of appropriate sterile fluids (saline or hydrogen peroxide) into the
external (secondary) opening of the fistula tract and identifying the site of
emergence at the internal (primary) opening can also be used to assist in
identifying the location of the internal opening.
NOTE: Failure to locate the internal (primary) opening may lead to
persistence of the fistula. If the internal (primary) opening cannot
be reliably identified, an alternative method of treatment should be
considered.
Both mechanical bowel cleansing and antibiotic prophylaxis of
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bacitracin, polymyxin B,
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(See Use of Antimicrobials)
For example, gentamicin is known to
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and vancomycin
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4
3 (See
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while
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have all been
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