COOK Medical Biodesign Surgisis Mode D'emploi page 4

STERILIZATION
This plug has been sterilized with ethylene oxide and should not be
resterilized.
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. Both mechanical bowel cleansing and antibiotic prophylaxis
1-3
of 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. 3 (See 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 plug is implanted.
• Maintain therapeutic levels of the agent in serum and tissues throughout
the operation.
3
The presence of certain antimicrobials may inhibit revascularization and/or
infiltration of cells into the repairing tissue.
to hinder neovascularization, epithelialization, and keratinocyte growth,
povidone iodine, 8 bacitracin,
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: Handle plug using aseptic technique. Minimize contact with latex gloves.
REQUIRED MATERIALS
• A sterile dish (kidney dish or other bowl)
• Rehydration fluid: at least 200 ml of 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)
• A short 14ga or 16ga catheter
• Saline or hydrogen peroxide for flushing
PREPARATION
1. Select the proper plug size according to Procedural step 4.
2. Remove the packaging containing the plug from the box.
3. Remove the inner pouch containing the plug from the outer package
using aseptic technique. Place the inner pouch into the sterile field.
4. Using sterile gloved hands carefully open the inner pouch and remove
the card containing the plug. Place the plug and card combination into
the sterile dish in the sterile field.
5. 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 no longer than 5 minutes.
6. Fold the card at the indicated line and carefully remove the hydrated plug
from the card.
7. Attach a suitable resorbable suture (approximately 30 cm in length)
through the tail (narrow end) of the plug for pulling it into the fistula
tract. Obtain at least a 4mm suture bite into the end of plug.
8. Prepare the patient and surgical site using standard surgical techniques
appropriate for the 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.
PROCEDURAL
1. Perform under local, regional, or general anesthesia.
2. If a seton is not already in place, identify the rectal (primary) fistula
opening by inserting a sterile probe into the secondary opening
and navigating it through the fistula tract. Alternatively, injection of
appropriate sterile fluids (saline or hydrogen peroxide) into the secondary
opening of the fistula tract, and identifying the site of emergence at the
primary opening, can also be used to assist in identifying the location of
the rectal fistula opening.
5-7 For example, gentamicin is known
5,8 polymyxin B, 9 and vancomycin
(See Use of Antimicrobials)
1-3
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