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(Collatamp/Garacol®)

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1 (Collatamp/Garacol®)
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
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 Since the introduction of preoperative neoadjuvant radiotherapy the incidence of perineal wound complication has gone up. The Dutch TME trial shows a two folt increase in wound infections which is confirmed by other studies. Preoperative radiotherapy multiplies perineal morbidity !

4 De Bruin AFJ et al. Tech Coloproctol 2008 Dec
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® 4

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) 30 29% 20 Patients with postoperative deep wound infection or abscess (%) 10 5% Control Collatamp® De Bruin AFJ et al. Tech Coloproctol 2008 Dec. 5

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 The collagen fleeces also accelerates haemostasis Haemostasis is triggered when blood comes into contact with released tissue factors and renatured collagen. The adhesion and aggregation of platelets is induced on the renatured collagen, accelerating the coagulation process. The sponge-like structure stabilises the wound clot. Finally, collagen also promotes granulation and epithelialisation as part of wound repair. 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 7

8 3. Stemberger A. Eur J Surg Suppl 1997;578:17-26.
Microbial resistence 3. Stemberger A, Grimm H, Bader F et al. Local treatment of bone and soft tissue infections with the collagen-gentamicin sponge. Eur J Surg Suppl 1997;578:17-26. 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) So what are the highest concentration in wound excretion of gentamicin after implantation? This was measured from wound excretion from a drain after implantation of 3 fleeces into a abdominal wound. It showed levels as high as 2000mg/l which is far above the threshold for 100% inhibition of mentioned pathogens Minimum inhibition concentration (MIC) 1 2 3 4 5 6 7 Day Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698 9

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 1 2 3 4 5 6 7 Day Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698 10

11 Microscopy collagen matrix pictures
Gentafleece Collatamp x200 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;578:31–35 221 patients undergoing elective colorectal surgery Systemic antibiotic cover with (n=107) or without (n=114) the use of Collatamp® 13 13

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 days; p=0.015) No adverse events related to Collatamp® 30 p<0.01 20 18.4% Patients with postoperative wound infection (%) 10 5.6% Systemic antibiotics only Collatamp® + systemic antibiotics Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35 14 14

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® 15 15

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

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
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

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

22 Letsch et al. Actualle traumatol 1993 osteomyelitis of long bones
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
90 % 80% 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. 100 complete resolution of osteomyelitis(%) 50 GCCI PMMA beads Letsch et al. Actualle traumatol 1993 23

24 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 ) 1950 patients analysed (73% CABG, 14% valves) Primary outcome: all sternal wound infections occurring within 2 months of surgery 10. Friberg O, Svedjeholm R, Soderquist B et al. Local gentamicin reduces sternal wound infections after cardiac surgery: A randomised controlled trial. Ann Thorac Surg 2005;79: Friberg O et al. Ann Thorac Surg 2005;79:

25 Sternal wound infections at 2 months
Re-operation rate for infection(p=0.021): 3,9% control 2,1 % GCCI(gentamicin collagen fleeces p<0.001 10. Friberg O, Svedjeholm R, Soderquist B et al. Local gentamicin reduces sternal wound infections after cardiac surgery: A randomised controlled trial. Ann Thorac Surg 2005;79: Friberg O et al. Ann Thorac Surg 2005;79:

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. 26

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: CFU/g Cefalozine: 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® 29 29

30 Pain scores

31 patients healed after 4 weeks
100 90% 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 90 80 70 60 Primary healing rate (%) 50 40 30 13% 20 10 Collatamp® No antibiotics Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009 31 31

32 Turkey the place to be for a hairy ass

33 Results 20% 5%

34 Treatment of groin wound graft infections
Vascular surgery Jorgensen et al Eur J Vasc Surg 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 re-operations Bacteriology: 6 Staph aureus 2 Pseudomonas aeruginosa 1 non-haemolytic Streptococcus (not sensitive to gentamicin) 5 sterile cultures 2. Jørgensen LG, Sørensen TS, Lorentzen JE. Clinical and pharmacokinetic evaluation of gentamycin containing collagen in groin wound infections after vascular reconstruction. Eur J Vasc Surg 1991;5:87-91. 34 34 Jorgensen et al Eur J Vasc Surg 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
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


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