Terveydenhuollon ammattilaisille

Septopal®

The further development of surgical techniques has enabled an improvement in treatment options. Nevertheless, postoperative and posttraumatic bone, soft-tissue and joint infections continue to be a major challenge in modern surgery, and are among the most serious complications that can occur. Not only do they cause greater stress to the affected patient, but they also lead to greater costs. Thanks to local antibiotic carriers, however, substantial progress has been made in this area.

Combined with complete surgical debridement, which is essential to treat bone and soft-tissue infections successfully, local antibiotic carriers should be part of the therapy-concept. Septopal® ensures high local concentrations of gentamicin at the site of infection, moreover systemic adverse effects of gentamicin are avoided.

 
The controlled pharmacokinetics of Septopal cause a high initial and protracted release of the antibiotic. This means that effective levels of gentamicin are also achieved in the deeper recesses of the wound. As a result, residual bacteria and microabscesses in deeper tissue layers are also caught and eliminated. These persistent bacteria (persisters) could otherwise lie dormant for period of time and then – depending on external influences – multiply again.
Such persisters often cause severe re-infections. The elimination of these residual bacteria by surgical intervention and adequate local antibiosis is mandatory.
Septopal® is the time-tested and reliable local antibiotic therapy that naturally supports surgical treatment since more than 25 years.

 

High therapeutic safety

Within a few hours after applying Septopal®, gentamicin concentrations are reached that are 10–100 times higher than the minimum bactericidal concentrations for the most important causative microbes. This leads to a rapid elimination of the pathogens. Compared to these high local concentrations, only traces of gentamicin were detectable in the serum for a few days after the operation. None of the concentrations measured exceeded 0.7 µg/ml. These values are thus far below the concentrations usual for systemic therapy (4–6 µg/ml).
 
 
 
 
 
 Release of gentamicin after implantation of 360 Septopal®-beads.
 
 
Complete and thorough surgical debridement at the site of infection is the essential requirement for treating infected bones and soft tissue successfully, combined with an effective local antibiotic therapy. The application of Septopal® can therefore be recommended for:
 

Bone infections, e.g.:

  • Post-traumatic osteomyelitis
  • Chronic forms of hematogenous osteomyelitis
  • Infected osteosynthesis
  • Infected pseudarthrosis
  • Two-stage-revisions of infected endoprostheses
  • Soft-tissue infections, such as:
    • Infected wounds
    • Abscesses
  • Preventive applications, such as: 
    • potentially infected open fractures
    • soft-tissue trauma

Features

  • Excellent antibiotic efficacy
  • High initial and protracted antibiotic release focused at the site of the infection
  • Low systemic antibiotic concentrations – no fear of gentamicin side effects
  • Serves as temporary spacer for 2-stage revisions
  • Septopal®-chains are available in 3 sizes (with 10, 30 or 60 beads), Septopal®-Mini-chains are available in 2 sizes (with 10 or 20 oval beads).
 
Literature:
 
(1) Dingeldein E.,Bacteriological studies in patients treated with gentamicin-PMMA beads (1980) In:van Rens Th.J.G.,Kayser F.H.,Local antibiotic treatment in osteomyelitis and soft-tissue infections,International Congress Series 556,S.18, Excerpta Medica
 
(2) Edgeworth J.D.,Treacher D.F.,Eykyen S.J.,A 25-year study of nosocomial bacteremia in an adult intensive care unit.Crit Care Med.1999;27 (8):1421-1428
 
(3) Forth W.,Henschler D.,Rummel W.,Allgemeine und spezielle Pharmakologie und Toxikologie (2001),8.Auflage, Urban & Fischer Verlag
 
(4) Grieben A.,Clinical results of Septopal in bone and soft-tissue infections. A survey of clinical trials (1980) In:van Rens Th.J.G.,Kayser F.H.,Local antibiotic treatment in osteomyelitis and soft-tissue infections, International Congress Series 556,S.144,Excerpta Medica
 
(5) Kayser F.H.,Eberle H.,Bacterial aspects of chronic posttraumatic osteomyelitis (1980) In:van Rens Th.J.G.,Kayser F.H.,Local antibiotic treatment in osteomyelitis and soft-tissue infections,International Congress Series 556,S.1,Excerpta Medica
 
(6) Kayser F.H.,Strässle A.,Vurma U.,Bacteriological aspects of deep wound sepsis in surgery and orthopaedics.Reconstr.Surg.Traumat.1988;Vol 20:1-1
 
(7) Klemm K.,Antibiotic bead chains.Clin.Orthop.1993 Oct;(295):63-76
 
(8) Klemm K.,The use of antibiotic-containing bead chains in the treatment of chronic bone infections.Clin.Microbiol.Infect.2001 Jan;7 (1):28-31
 
(9) Knaepler H.,Klemm K.,Dingeldein E.,Wahlig H.,Gentamicin-PMMA-Miniketten in der septischen Knochen-und Weichteilchirurgie. Unfallchirurg.1985 Oct;88 (10):457-64
 
(10) Liener U.C.,Suger G.,Kinzl L.,Knochen-und Gelenkinfektionen (2001)In:Wirth C.J.,Praxis der Orthopädie,Band II,3.Auflage,Thieme Verlag
 
(11) Wahlig H.,Gentamicin-PMMA beads,a drug delivery system;basic results(1980) In:van Rens Th.J.G.,Kayser F.H.,Local antibiotic treatment in osteomyelitis and soft-tissue infections,International Congress Series 556,S.9,Excerpta Medica
 
(12) Wahlig H.,Dingeldein E.,Bergmann R.,Reuss K.,The release of gentamicin from polymethylmethacrylate beads.An experimental and pharmacokinetic study. J.Bone Joint Surg.Br.1978 May;60-B (2):270-5
 
(13) Walenkamp G.H.I.M.,Pharmacological and clinical results with gentamicin-PMMA beads in osteomyelitis (1998) In:Walenkamp G.H.I.M.,Biomaterials in Surgery,S.55,Thieme Verlag
 
(14) Schmidt Hergo G.K.,Gerlach U.,Wurm M.,Grosser V.,Diagnostik und Therapie von Schulter-und Ellengelenkempyemen. Trauma Berufskrankheit,3 (Suppl 3):404-414 (2001)
 
(15) Bühler M.,Schmidt Hergo G.K.,Börner M.,Infektionen nach Verletzungen am Fuß.Trauma Berufskrankheit,3:240-243 (2001)
 
(16) Bonnaire F., Hohaus T., Cyffka R., Lein T. Knocheninfektionen.Unfallchirurg 73:716-733 (2002)
 
(17) Schnettler R.,Akute und posttraumatische Osteitis (2004) In:Schnettler R.,Steinau H.-U.,Septische Knochenchirurgie,S.96 ff.,Thieme-Verlag
 
(18) Walenkamp G.H.I.M.,Vree T.B.,van Rens Th.J.G.,Gentamicin-PMMA Beads,Clin.Orthop.1986 April;(205):171-183
 
(19) Frommelt L.,Lokale Antibiotikatherapie (2004) In:Schnettler R.,Steinau H.-U.,Septische Knochenchirurgie,S.82 ff.,Thieme-Verlag