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Antibiotic Bonding

5 minute procedure

Up to 5 days antibiotic activity

  • Vascutek gelatin sealed vascular grafts form an ionic bond with the antibiotic Rifampicin
  • This has the potential to minimise the occurrence of post-operative graft infection
  • The gelatin and Rifampicin ionic bond can withstand flow and is not simply washed out
  • The procedure is suitable for both Vascutek gelatin sealed Polyester and gelatin sealed ePTFE grafts

Antibiotic Bonding to Vascutek gelatin sealed ePTFE

Antibiotic Bonding to Vascutek Polyester

Antibiotic Bonding to Vascutek
gelatin sealed ePTFE
Antibiotic Bonding to
Vascutek Polyester

 

* This application of antibiotics has not been approved by the FDA for use in the USA or by TPD for use in Canada and is subject to local regulatory approval in all other countries

Literature

Antibiotic Bonding - Instructions for Use

Select the appropriate flag to download the Instructions for Use PDF file in the language of your choice.

Alternatively, right-click on the flag and select the 'Save Target As..' option to save the file for off-line viewing.

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Danish Dutch English French German Greek
Italian IFU Japanese Nowegian Portugese Spanish IFU Swedish
Italian Japanese Norwegian Portugese Spanish Swedish

 

FAQs

Frequently Asked Questions

Rifampicin Bonding to Vascutek Gelatin Sealed Products*

1. How does Rifampicin bond with the gelatin used by Vascutek Ltd.?

The unique patented gelatin sealant used by Vascutek is made by partial succinylation of standard gelatin. This involves a molecular change where carboxyl groups replace some of the amino groups. Ionic bonding occurs between the methyl group on the antibiotic Rifampicin and carboxyl groups on the gelatin during a simple soaking procedure prior to implantation1.

Ionic Bonding of Rifampicin with Vascutek Gelatin

The antibiotic is gradually released over a period of up to 5 days at a level to provide potential postoperative graft infection control2,3,4, in addition to standard systemic cover.

References (Click to expand) 

  1. Strachan C. et al.
    The Clinical use of an Antibiotic Bonded Graft.

    Eur J. Vasc Surg (1991), 5, 627-632.
  2. Ashton T et al.
    Antibiotic Loading of Vascular Grafts.

    Transactions of the 16th Meeting of the Society for Biomaterials, 13:235; 1990.
  3. Strachan C. et al.
    Prosthetic Graft Infection.

    Critical Ischaemia (1993), Vol 2, No. 3, 5-16.
  4. Goëau-Brissonnière, O. et al.
    Treatment of Vascular Graft Infection by In Situ Replacement with a Rifampicin Bonded Gelatin-Sealed Dacron® Graft.

    J Vasc Surg (1994) 19:4; 739-744.

2. Why specifically use Rifampicin for antibiotic bonding and postoperative graft infection control?

Rifampicin is widely available and used for the treatment of tuberculosis and meningitis.

The main reasons why Rifampicin is chosen in preference to other antibiotics are:

  • A strong ionic bond is formed with Vascutek modified gelatin
  • Activity against Staphylococci - responsible for the majority of postoperative graft infections2
  • The orange colour allows the user to see that the graft is completely covered in antibiotic solution
  • Inexpensive and readily available

This technique should be used in association with and not as a replacement for normal prophylactic antibiotic cover.

Additional research in vivo has indicated that Rifampicin may be a useful antibiotic in selected cases of MRSA1,2

References (Click to expand) 

  1. Goëau-Brissonnière O et al.
    Prevention of Vascular Graft Infection by Rifampicin Bonding to a Gelatin Sealed Dacron® Graft.
    Ann Vasc Surg (1991) 5,5; 408-412.
  2. Vicaretti M et al.
    An Increased Concentration of Rifampicin bonded to Gelatin Sealed Dacron® reduces the risk of subsequent Graft Infections following Staphylococcal Challenge. 
    Cardiovasc Surg (1998) 6:3; 268-273.

3. What procedure should I follow in order to bond Rifampicin to your gelatin sealed grafts?

  • All Vascutek gelatin sealed grafts can be bonded with Rifampicin in accordance with the product instruction for use
  • Simply soak the graft with a 12mg/ml Rifampicin/saline solution for 5 minutes*
  • Drain excess solution from the graft prior to implantation.

Stage 1

Stage 2

Stage 1

Fill syringe to 40ml with sterile saline

Stage 2

Reconstitute 600mg of Rifampicin with the
10ml of diluent provided

Stage 3

Stage 4

Stage 3

Draw up 10ml of Rifampicin solution
from stage 2 into the 50ml syringe
to give a total volume of 50ml

Stage 4

Inject the Rifampicin/saline solution through
the Tyvek lid of the blister containing the graft,
taking care not to damage the graft. Rock the
blister to ensure complete coverage
of the graft

Stage 5

Stage 5

After 5 minutes the graft can be removed.
Excess solution is allowed to drain before
the graft is implanted


Standard operating room practice should be followed throughout this procedure to ensure that the sterility of the graft and of any other item is not compromised

4. What Rifampicin concentrations should I use and in what circumstances?

A number of different regimes have been used.

Animal studies have shown that grafts soaked in a 1 mg/ml antibiotic solution are successful in minimising the incidence of post-operative graft infection 1,2*.

This approach was confirmed clinically by the Rifampin Bonded Graft European Trial (RBGET, prospective, randomised and multi-centred) involving over 2500 implants. A significant reduction in the incidence of combined post-operative wound and graft infections was seen3.

For the more challenging circumstances of in situ replacement, several authors have successfully used a 60 mg/ml regime4,5. It should be noted, however, that due to the insoluble nature of Rifampicin, this may be a limiting factor in the concentrations that may be achieved.

For full details, please consult the product Instructions for Use

* This application of antibiotics has not been approved by the FDA for use in the USA or by TPD for use in Canada and is subject to local regulatory approval in all other countries.

References (Click to expand) 

  1. Lachapelle K et al.
    Antibacterial Activity, Antibiotic Retention and Infection Resistance of a Rifampicin-Impregnated Gelatin-Sealed Dacron Graft.

    Journal of Vascular Surgery, 19 : 675-682, 1994.
  2. Goëau-Brissonnière O et al.
    Prevention of Vascular Graft Infection by Rifampin Bonding to a Gelatin-Sealed Dacron Graft.

    Annals of Vascular Surgery, 5: 5; 408-412, 1991.
  3. Goëau-Brissonnière O et al.
    Rifampin Bonded Graft.
    European Trial Symposium. May, 1995.
  4. Strachan C et al.
    The Clinical Use of an Antibiotic-bonded Graft.

    Eur J Vasc Surg 5, 627-632 (1991).
  5. Naylor A R et al.
    Treatment of Major Aortic Graft Infection: Preliminary Experience with Total Graft Excision and In Situ Replacement with a Rifampicin Bonded Prosthesis.

    Eur J Vasc Endovasc Surg (1995); 9, 252-256. 

Draw up 10ml of Rifampicin solution from stage 2 into the 50ml syringe to give a total volume of 50ml

Contact Vascutek

VASCUTEK, a TERUMO Company
Registered Office:
Newmains Avenue
Inchinnan
Renfrewshire PA4 9RR
Scotland UK

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Tel: 00 44 141 812 5555
Fax: 00 44 141 812 7170


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