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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 Author Journal APR APR + Rtx p-value Marijnen et al J Clin Oncol 2002 18% 29% 0.008 Vallero et al. Int J Colorectal Dis 2003 26% 45% - Bullard et al. Dis Colon Rectum 2005 23% 47% 0.005 Preoperative radiotherapy multiplies perineal morbidity ! 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® postoperative deep wound infection or abscess p=0.05 Patients with postoperative deep wound infection or abscess (%) 30 •Superficial perineal wound complications occurred in 11% of the Collatamp® group and 29% of the control group (p=0.15) 29% 20 •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) 10 5% 0 Control Collatamp® De Bruin AFJ et al. Tech Coloproctol 2008 Dec. Gentamicin collagen fleeces • Aminoglycoside: • Gram negative: • Gram positive: Strong bactericide Pseudomonas, Entrobacter, Klebsiella 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 Collagen fleeces Fibrinolysis: thrombin cleaves fibrinogen allowing fibrin polymerisation Polymerised fibrin fibres (clot) Thrombin Binding of the platelet collagen receptor to collagen leads to activation of platelets Activation of surface glycoprotein 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 Microbial resistence 3. Stemberger A. Eur J Surg Suppl 1997;578:17-26. High local concentrations of gentamicin Gentamicin tissue concentration (mg/L) 2000 After implantation of 3 units (total gentamicin sulphate dose 600 mg) into a postoperative abdominal wound Minimum inhibition concentration (MIC) 0 1 2 3 Day 4 5 6 7 Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698 Low serum levels of gentamicin Gentamicin serum concentration (µg/mL) 4 Minimum inhibition concentration (MIC) After implantation of 3 units (total gentamicin sulphate dose 600 mg) into a postoperative abdominal wound 2 0 1 2 3 Day 4 5 6 7 Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698 Microscopy collagen matrix pictures Collatamp Gentafleece x200 Collatamp’s Collagen Matrix Carrier has a highly cross-linked Fine-Fibril-Matrix compared to Gentafleece x200 Diptest data – impact of soaking Gentamicin Content Lost (%) 120 100 80 60 40 20 0 0 50 100 150 200 250 300 Immersion time (min) Andrew M Lovering, Julie Sunderland; Antimicrobial Reference Laboratory, North Bristol NHS Trust, Bristol, BS10 5NB, United Kingdom 350 400 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® Clinically proven efficacy of Collatamp® in GI surgery Patients with postoperative wound infection (%) 30 20 •3-fold decrease in wound infection rates; (p<0.01) p<0.01 •Significantly shorter hospital stay (13.8 days vs 16.3 days; p=0.015) 18.4% 10 5.6% •No adverse events related to Collatamp® 0 Systemic antibiotics only Collatamp® + systemic antibiotics Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35 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® Postoperative perineal wound infection P=0.01 •Eradication of enterobacteria, staphylococci and Pseudomonas aeruginosa in 84% of Genta patients versus 60% controls (P 0.013). Patients with postoperative perineal wound infection (%) 30 25% 20 12 % 10 •4% Deep wound infection treatment group versus 10% control group 0 Systemic antibiotics only Collatamp® + systemic antibiotics Gruessner, et al. 2001 Collatamp vs PMMA Chains local concentrations of gentamicin in the wound (mg/L) Gentamicin tissue concentration (mg/L) MIC for resistent pathogens (300 mg/L) small PMMA Chains MIC for sensitive pathogens(4 mg/L) PMMA Chains Collatamp® Time Adapted from Swieringa, et al..(2008)Acta Orthopaedica,79:5,637 —642 Biomaterial-associated infection of gentamicin-loaded PMMA beads in orthopaedic revision surgery Daniëlle Neuta,b, Hilbrand van de Belta et al. Journal of Antimicrobial Chemotherapy (2001) • 20 patients with prosthesis-related infections • Gentamicin loaded beads in two-stage orthopaedic revision surgery Gentamicin loaded beads 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 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 revision operations p=0.0001 Revision operations(%) 100 50 0 67% • Local wound healing criteria p=0.34 20 % GCCI PMMA beads D. Bettin et al. J Bone Joint Surg Br 2009 Local antibiotic administration in osteomyelitis treatment--a comparative study with two different carrier substances Letsch et al. Actualle traumatol 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 complete resolution of osteomyelitis 90 % 80% The number of re-operations was significantly group I 1.1 vs 1.9 complete resolution of osteomyelitis(%) 100 50 • 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. 0 GCCI PMMA beads Letsch et al. Actualle traumatol 1993 Cardiothoracic surgery Evaluation of the impact of COLLATAMP on the incidence of post-operative sternal wound infections 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 Sternal wound infections at 2 months Infection rate (%) 10 • Re-operation rate for infection(p=0.021): 9 8 6 4,3 4 2 – 3,9% control – 2,1 % GCCI(gentamicin collagen fleeces p<0.001 0 Systemic antibiotics (n=967) COLLATAMP G + systemic antibiotics (n=983) Friberg O et al. Ann Thorac Surg 2005;79:153-161. Collatamp® and orthopaedic surgery Therapy with gentamicin-PMMA beads, gentamicincollagen sponge,and cefazolin for experimental osteomyelitis due to Staphylococcus aureus in rats V. Mendel et al. Arch Orthop Trauma Surg (2005) Rat model for Staphylococcus aureus-induced osteomyelitis 150 rats radiographic confirmed osteomyelitis undergoing debridement and randomization in to four groups. Gentamicin; PMMA chains versus Collagen(Collatamp®) • Goups: – No treatment – Cefazoline – Gentamicine PMMA chains + Cefazoline – Gentamicin collagen fleeces + Cefazoline Mendel et al. Arch Orthop Trauma Surg 2005 Results after four weeks • All rats in treatment groups stage 1 infection • All rats in control group stage 3 en 4 • Bacteriën – – – – Control group: Cefalozine: Gentamicin PMMA Gentamicin collagen 106 CFU/g 104 CFU/g 102 CFU/g in 81% no bacteria Mendel et al. Arch Orthop Trauma Surg 2005 ® 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® Pain scores patients healed after 4 weeks p<0.001 Primary healing rate (%) 100 90% •Mean time to wound healing Group I: 10 days vs Group II: 50 days (p<0.001) 90 80 70 60 •LOS: There was no difference seen between the two groups in length of hospital stay 50 40 30 13% 20 10 0 Collatamp® •No difference long-term recurrence rate No antibiotics Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009 Turkey the place to be for a hairy ass Results 20% 5% Vascular surgery Jorgensen et al Eur J Vasc Surg 5 1991 Treatment of groin wound graft infections • 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 reoperations • Bacteriology: • 6 Staph aureus • 2 Pseudomonas aeruginosa • 1 non-haemolytic Streptococcus (not sensitive to gentamicin) • 5 sterile cultures 34 2. Jørgensen LG et al. Eur J Vasc Surg 1991;5:87-91. Jorgensen et al Eur J Vasc Surg 5 1991 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 Cost – benefit • Cost 10 cm x 10 cm = 90 € • Adverse impact of SSI Median LOS without SSI (days) Extra LOS with SSI*(days) Extra costs due to SSI (€) Limb amputation 13.2 21.0 6940 ORLBF 9.6 9.9 3270 Hip prothesis 11.1 11.5 3780 Knee prosthesis 10.3 10.9 3601 *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