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

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Presentation on theme: "Gentamicin collagen fleeces (Collatamp/Garacol (Collatamp/Garacol®) A.F.J. De Bruin."— Presentation transcript:

1 Gentamicin collagen fleeces (Collatamp/Garacol (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 AuthorJournalAPRAPR + Rtx p-value Marijnen et al J Clin Oncol %29%0.008 Vallero et al. Int J Colorectal Dis %45%- Bullard et al. Dis Colon Rectum %47%0.005 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 Patients underwent complete closure of the pelvic peritoneal floor, sacral drainage and multiple layer wound closure with or without Garacol ® 40 patients undergoing abdominoperineal resection for rectal cancer after short-course radiotherapy

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) % 5% p=0.05 ControlCollatamp ® De Bruin AFJ et al. Tech Coloproctol 2008 Dec. Patients with postoperative deep wound infection or abscess (%)

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 Initiation of haemostasis by tissue factor receptors in renatured collagen Thrombin Binding of the platelet collagen receptor to collagen leads to activation of platelets Activation of surface glycoprotein Aggregation of platelets Polymerised fibrin fibres (clot) Fibrinolysis: thrombin cleaves fibrinogen allowing fibrin polymerisation 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 Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698 Day Minimum inhibition concentration (MIC) After implantation of 3 units (total gentamicin sulphate dose 600 mg) into a postoperative abdominal wound Gentamicin tissue concentration (mg/L)

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

11 Microscopy collagen matrix pictures Gentafleece Collatamp x200 Collatamp’s Collagen Matrix Carrier has a highly cross-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– 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 ® 18.4% 5.6% p< Systemic antibiotics only Collatamp ® + systemic antibiotics Patients with postoperative wound infection (%) 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 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 25% 12 % P= Systemic antibiotics only Collatamp ® + systemic antibiotics Patients with postoperative perineal wound infection (%) Gruessner, et al Postoperative perineal wound infection

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

18 Biomaterial-associated infection of gentamicin-loaded PMMA beads in orthopaedic revision surgery 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 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

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= % 67% p= GCCIPMMA beads D. Bettin et al. J Bone Joint Surg Br 2009 Revision operations (%)

22 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

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 %80% GCCIPMMA beads Letsch et al. Actualle traumatol 1993 complete resolution of osteomyelitis (%)

24 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 ) 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: Cardiothoracic surgery

25 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: p<0.001

26 Collatamp ® and orthopaedic surgery Therapy with gentamicin-PMMA beads, gentamicin- collagen 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.

27 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

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:10 6 CFU/g – Cefalozine: 10 4 CFU/g – Gentamicin PMMA10 2 CFU/g – Gentamicin collagenin 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 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< % 90% No antibiotics Primary healing rate (%) Collatamp ® Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009

32 Turkey the place to be for a hairy ass

33 20% 5% Results

34 Treatment of groin wound graft infections 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 2. Jørgensen LG et al. Eur J Vasc Surg 1991;5: Vascular surgery Jorgensen et al Eur J Vasc Surg

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 Median LOS without SSI (days) Extra LOS with SSI*(days) Extra costs due to SSI (€) Limb amputation ORLBF Hip prothesis Knee prosthesis *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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