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A.F.J. De Bruin

Gentamicin collagen fleeces ( Collatamp / Garacol ®). A.F.J. De Bruin. Abdominalperineal resection (APR). Ernest Miles 1908 Perineal infection up to 70%. Wound infection after APR + RTX. Preoperative radiotherapy multiplies perineal morbidity ! .

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A.F.J. De Bruin

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  1. Gentamicin collagen fleeces (Collatamp/Garacol®) A.F.J. De Bruin

  2. Abdominalperineal resection (APR). • Ernest Miles 1908 • Perineal infection up to 70%

  3. Wound infection after APR + RTX Preoperative radiotherapy multiplies perineal morbidity !

  4. Local gentamicin reduces perineal wound infection after radiotherapy and abdominoperineal resection De Bruin AFJ et al. Tech Coloproctol 2008 Dec 40 patients undergoing abdominoperineal resection for rectal cancer after short-course radiotherapy Patients underwent complete closure of the pelvic peritoneal floor, sacral drainage and multiple layer wound closure with or without Garacol®

  5. postoperative deep wound infection or abscess Superficial perineal wound complications occurred in 11% of the Collatamp® group and 29% of the control group (p=0.15) Only 5% of patients developed a deep wound infection or abscess in Collatamp® group compared with 29% of patients in control group (p=0.05) p=0.05 29% 30 20 Patients with postoperative deep wound infection or abscess (%) 10 5% 0 Control Collatamp® De Bruin AFJ et al. Tech Coloproctol 2008 Dec.

  6. Gentamicin collagen fleeces • Aminoglycoside: Strong bactericide • Gram negative: Pseudomonas, Entrobacter, Klebsiella • Gram positive: Staphylococci • NO effect on osteoblasts • Gentamicin fleeces (Collatamp®=Garacol®): • Collagen impregnated with Gentamicin • Concentration exsudaat stays high during short period and diminish fast. • Re-absorbable • Measurements; 5x5 cm(32,gmg) or 10x10cm(130mg) • No biofilm formation

  7. Collagen fleeces Fibrinolysis: thrombin cleaves fibrinogen allowing fibrin polymerisation Polymerised fibrin fibres(clot) Thrombin Activation of surface glycoprotein Binding of the platelet collagen receptor to collagen leads to activation of platelets Aggregation of platelets Initiation of haemostasis by tissue factor receptors in renatured collagen Hakim NS & Canelo R. (2007) Haemostasis in Surgery. Imperial College Press; Stemberger A et al. Eur J Surg 1997;Suppl 578:17–26

  8. Microbial resistence 3. Stemberger A. Eur J Surg Suppl 1997;578:17-26.

  9. High local concentrations of gentamicin 2000 After implantation of 3 units (total gentamicin sulphate dose 600 mg) into a postoperative abdominal wound Gentamicin tissue concentration (mg/L) Minimum inhibition concentration (MIC) 0 3 7 1 4 6 2 5 Day Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698

  10. Low serum levels of gentamicin 4 Minimum inhibition concentration (MIC) After implantation of 3 units (total gentamicin sulphate dose 600 mg) into a postoperative abdominal wound Gentamicin serum concentration (µg/mL) 2 0 3 7 1 4 6 2 5 Day Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698

  11. Microscopy collagen matrix pictures Collatamp Gentafleece x200 x200 Collatamp’s Collagen Matrix Carrier has a highlycross-linked Fine-Fibril-Matrix compared to Gentafleece

  12. Diptest data – impact of soaking Andrew M Lovering, Julie Sunderland;Antimicrobial Reference Laboratory, North Bristol NHS Trust, Bristol, BS10 5NB,United Kingdom

  13. Collatamp® and gastrointestinal (GI) surgery Prevention of wound infection in elective colorectal surgery by local application of a gentamicin-containing collagen implant Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35 221 patients undergoing elective colorectal surgery Systemic antibiotic cover with (n=107) or without (n=114) the use of Collatamp®

  14. Clinically proven efficacy of Collatamp® in GI surgery 3-fold decrease in wound infection rates; (p<0.01) Significantly shorter hospital stay (13.8 days vs 16.3 days; p=0.015) No adverse events related to Collatamp® p<0.01 30 20 18.4% Patients with postoperative wound infection (%) 10 5.6% 0 Systemic antibiotics only Collatamp® + systemic antibiotics Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35

  15. Gentamicin collagen Fleeces and gastrointestinal (GI) surgery Improvement of perineal wound healing by local administration of gentamicin-impregnated collagen fleeces after abdominoperinealexcision of rectal cancer Gruessner and Clemens, et al. The American Journal of Surgery 2001 97 patients undergoing elective abdominal perineal resection Systemic antibiotic cover with (n=49) or without (n=48) the use of Collatamp®

  16. Eradication of enterobacteria, staphylococci and Pseudomonas aeruginosa in 84% of Genta patients versus 60% controls (P 0.013). 4% Deep wound infection treatment group versus 10% control group Postoperative perineal wound infection P=0.01 30 25% 20 Patients with postoperative perineal wound infection (%) 12 % 10 0 Systemic antibiotics only Collatamp® + systemic antibiotics Gruessner, et al. 2001

  17. Collatamp vs PMMA Chains local concentrations of gentamicinin the wound (mg/L) MIC for resistent pathogens (300 mg/L) small PMMAChains MIC for sensitive pathogens(4 mg/L) Gentamicin tissue concentration (mg/L) PMMA Chains Time  Collatamp® Adapted from Swieringa, et al..(2008)Acta Orthopaedica,79:5,637 —642

  18. Biomaterial-associated infection of gentamicin-loaded PMMA beads inorthopaedicrevisionsurgery • 20 patients with prosthesis-related infections • Gentamicin loaded beads in two-stage orthopaedic revision surgery Daniëlle Neuta,b, Hilbrand van de Belta et al. Journal of Antimicrobial Chemotherapy (2001)

  19. Gentamicinloadedbeads Cocci Presence of bacteria on gentamicin loaded beads in 18 of the 20 patients 12 of these 18 patients considered free of infection 9 cultures MIC >256mg/l

  20. COMPARATIVE EVALUATION OF RESULTS AFTER LOCAL ANTIBIOTIC THERAPY WITH GENTAMYCIN IN FORM OF BEADS AND FLEECE D. Bettin et al. J Bone Joint Surg Br 2009 Chronic osteomyelitis 108 patients undergoing debridement and local application of gentamicin Prospective serie: 54 patients PMMA beads group and 54 patient in GCCI group

  21. revision operations Local wound healing criteria p=0.34 p=0.0001 100 67% Revision operations(%) 20 % 50 0 GCCI PMMA beads D. Bettin et al. J Bone Joint Surg Br 2009

  22. Local antibiotic administration in osteomyelitis treatment--a comparative study with two different carrier substances Letsch et al. Actualletraumatol 1993 osteomyelitis of long bones 20 patients undergoing debridement and local application of gentamicin Prospective serie: 10 patients PMMA beads group and 10 patient in GCCI group

  23. complete resolution of osteomyelitis The number of re-operations was significantly group I 1.1 vs 1.9 Release characteristics: Group I: Local levels of 1400 mg/l at 6 hours post-insertion & non-therapeutic levels in plasma Group II: Local levels of 100 mg/l at 3 hrs post-insertion. 90 % 80% 100 complete resolution of osteomyelitis(%) 50 0 GCCI PMMA beads Letsch et al. Actualle traumatol 1993

  24. Evaluation of the impact of COLLATAMP on the incidence of post-operative sternal wound infections Cardiothoracic surgery • Friberg et al, Ann Thorac Surg 2005 • Prospective, randomised, double blind trial (recruited 2000-02) • 1950 patients analysed (73% CABG, 14% valves) • Primary outcome: all sternal wound infections occurring within 2 months of surgery Friberg O et al. Ann Thorac Surg 2005;79:153-161

  25. p<0.001 Sternal wound infections at 2 months • Re-operation rate for infection(p=0.021): • 3,9% control • 2,1 % GCCI(gentamicin collagen fleeces Friberg O et al. Ann Thorac Surg 2005;79:153-161.

  26. Therapywithgentamicin-PMMAbeads, gentamicin-collagensponge,and cefazolin for experimental osteomyelitis due to Staphylococcus aureus in rats V. Mendelet al. ArchOrthop Trauma Surg (2005) Rat model for Staphylococcus aureus-induced osteomyelitis Collatamp® and orthopaedic surgery 150 rats radiographic confirmed osteomyelitis undergoing debridement and randomization in to four groups.

  27. Gentamicin; PMMA chainsversus Collagen(Collatamp®) • Goups: • No treatment • Cefazoline • Gentamicine PMMA chains + Cefazoline • Gentamicin collagen fleeces + Cefazoline • Mendel et al. Arch Orthop Trauma Surg 2005

  28. Results after four weeks • All rats in treatment groups stage 1 infection • All rats in control group stage 3 en 4 • Bacteriën • Control group: 106 CFU/g • Cefalozine: 104 CFU/g • Gentamicin PMMA 102 CFU/g • Gentamicin collagen in 81% no bacteria • Mendel et al. Arch Orthop Trauma Surg 2005

  29. Collatamp® and Pilonidal sinus A prospective randomised study comparing two treatment modalities for chronic pilonidal sinus with a 5-year follow-up Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009 60 patients undergoing excision and primary suture of pilonidal sinus Surgical procedure with (n=30) or without (n=30) the use of Collatamp®

  30. Pain scores

  31. patients healed after 4 weeks Mean time to wound healing - Group I: 10 days vs Group II: 50 days (p<0.001) LOS: There was no difference seen between the two groups in length of hospital stay No difference long-term recurrence rate p<0.001 100 90% 90 80 70 60 Primary healing rate (%) 50 40 30 13% 20 10 0 Collatamp® No antibiotics Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009

  32. Turkey the place to be for a hairy ass

  33. Results 20% 5%

  34. Treatment of groin wound graft infections Vascularsurgery Jorgensen et al Eur J VascSurg5 1991 • 10 months prospective follow up (range 6-15 months) of 14 cases of graft infection following vascular reconstruction • 1 COLLATAMP® implant • Results: • 13/14 (93%) healed, 1 case failed: required multiple re-operations • Bacteriology: • 6 Staph aureus • 2 Pseudomonas aeruginosa • 1 non-haemolytic Streptococcus (not sensitive to gentamicin) • 5 sterile cultures Jorgensen et al Eur J VascSurg 5 1991 34 34 2. Jørgensen LG et al. Eur J Vasc Surg 1991;5:87-91.

  35. Vaatstudie MUMC/ Atrium • ‘PREVENTION OF SURGICAL SITE INFECTION AT THE GROIN AFTER FEMORAL • ARTERIAL EXPOSURE USING LOCAL GENTAMYCIN SPONGE • PROSPECTIVE, RANDOMISED, CONTROLLED TRIAL’ • drs. B.J. Telgenkamp (projectleider) Atrium • dr. J.W. Daemen (begeleider) MUMC • drs. A.G. Krasznai (begeleider) Atrium • dr. P. Boelens MUMC

  36. Cost – benefit • Cost 10 cm x 10 cm = 90 € • Adverse impact of SSI *Adjusted by age, sex, preoperative stay, ASA score, wound class, duration operation, multiple procedures, emergency, trauma Coello et al. J Hosp Infect 2005;60:93-103

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