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Table 1 A summary of important studies on the use of GCCI (Gentamycin Containing Collagen Implants) in cardiac surgery

From: Role of topical application of gentamicin containing collagen implants in cardiac surgery

Authors Study design, n = Number of Subjects Treatment groups Results
Friberg O et al. [2], 2005 LOGIP Trial Double blind, Randomized, controlled, two-centre study. Patients undergoing cardiac surgery through median sternotomy - including operations in the ascending aorta. n = 1950 total patients Wound infection (<2 months post-operatively):
Treatment Gr (Gr I): Collatamp between the Sternal edges (n = 983) Group I vs Group II 4.3% vs 9.0% (RR 0.47; p < 0.001)
Control Gr (Gr II): Standard closure (n = 967) Early reoperation for bleeding was more common in the treatment group (4.0% vs 2.3%, p = 0.03).
N = 1950 Standard antibiotic prophylaxis given to both groups
  Need for postoperative antibiotic treatment: Group I: 11.6% vs Group II: 18.0% (RR 0.64: p < 0.001)
Evaluation: Double blind, ITT
Friberg O et al. [33], 2009 Prospective study, n = 2326 total patients Wound infection (<60 days postoperative):
Two centre study
(Control Gr from LOGIP Trial) Treatment Gr (Gr I): n = 1359 Group I vs Gr II 3.7% vs 9.0% p < 0.001
Control Gr (Gr II): n = 967 Surgical revision: Group I vs Group II 1.8% vs 3.9% (p < 0.001)
Standard antibiotic prophylaxis given to both groups
Eklund et al. [7], 2005 Randomised, Controlled Trial, Single-centre study. n = 542 total patients Wound infection (<3 months post-operatively):
Treatment Gr (Gr I): n = 272
Group I vs Group II 4.0% vs. 5.9% (p = n.s.)
Control Gr (Gr II):
Evaluation: Partially Blinded n = 270 Incidence of mediastinitis: 1.1% vs 1.9% (P value = NS)
Standard antibiotic prophylaxis given to both groups. Any patient staying in hospital for >72 hrs received IV Vancomycin in addition to routine IV Cefuroxime.
Schersten et al. [28], 2007 Prospective Study with historical controls n = 2026 total patients Wound infection (mediastinitis): Group I vs Group II
Treatment Gr (Gr I): n = 1091
Control Gr (Gr II): 0.75% vs 1.9%
n = 935 (p < 0.05)
Standard antibiotic prophylaxis given to both groups
Leyh et al. [51], 1999 Observational Study N = 42 Patients of DSWI after cardiac surgery were treated with Collatamp with or without other surgical interventions No definite conclusion regarding direct benefit of Collatamp use can be drawn from this study.
(No Control Group) Impact of GCCI on treatment of DSWI, to assess side effects of Gentamycin topical use, and Gentamycin
High (bactericidal) local levels of Gentamycin noted in mediastinal fluid
level in mediastinal fluid
Bennett-Guerrero et al. [67], 2010 Randomised, Controlled Trial, Single blind, n = 1502 total patients Wound infection (<90 days post-operatively):
Patients with diabetes n = 1006 [67%] Incidence of all types of wound infection Group I Vs Gr II 8.4% vs 8.7% (p value = n.s.)
Multicentre study Patients with BMI > 30, n = 1137 [76%]
Patients undergoing cardiac surgery and at high-risk for sternal wound infection (diabetes, BMI > 30 or both)
Incidence of DSWI Group I: 1.9% vs. 2.5% (p value = n.s.)
Treatment Gr (Gr I): n = 753
Control Gr (Gr II):  
n = 749
Standard antibiotic prophylaxis given to both groups
  Incidence of SSWI Group I: 6.5% vs. 6.1% (p value = n.s.)
Re-hospitalisation for sternal wound infection (<90 days post-operatively): Group I: 3.1% vs 3.2% (p value = n.s.)
Birgand et al. [68], 2013 Quasi-experimental prospective study (single-centre) n = 552 total patients Intervention period DSWI incidence rate: Intervention period
patients managed with GCCI n = 175 patients managed with GCCI: 12.6%
Diabetic and/or overweight patients undergoing CABG with bilateral internal mammary artery grafts.
Intervention period patients managed without GCCI n = 88 Intervention period patients managed without GCCI: 6.8%
Retrospective Control Gr, preintervention era group n = 289 Retrospective Control Gr, preintervention era group: 13.8%
No statistically significant differences between three groups.
The group managed with the sponge had a higher proportion of gentamicin-resistant micro-organisms.
The end-point was the rate of reoperation for deep sternal wound infection.  
Cohen et al. [73], 2010 Retrospective Case series n = 216 total patients Wound infection: Group I vs Gr II: 0.0% vs 9.0% (p value = 0.0220).
Treatment Gr (Gr I): n = 108
Control Gr (Gr II):
n = 108
Raja et al. [50], 2011 Patient case series n = 194 total patients Wound infection: Incidence of SSWI Group I vs Gr II: 2.1% vs 6.2% (p value = 0.01). Incidence of DSWI Group I vs Gr II: 2.1% vs 3.1% (p value = n.s)
Patients undergoing cardiac surgery via sternotomy Treatment Gr (Gr I): n = 97
Control Gr (Gr II):
n = 97
Standard antibiotic prophylaxis given to both groups
Schimmer et al. [74], 2012 Randomised, Controlled Trial, Double blind n = 723 total patients Wound infection (<30 days):
Treatment Gr (GrI) GCCI Gr, Collagen Implant with Gentamycin: n = 354
Incidence of SSWI/DSWI
Single-centre study
(Group I vs Gr II)
0.56%/1.9% vs
3.52%/2.9%
(p = 0.013)
Comparison of a GCCI versus a simple Collagen sponge Control Gr (Gr II) Simple collagen implant without Gentamycin:  
n = 369
Standard antibiotic prophylaxis given to both groups
Creanor et al. [12], 2012 Meta-analysis of randomised controlled trials Three randomised controlled trials (published between 2005 and 2010) involving 3,994 patients There is insufficient evidence of the effectiveness (or otherwise) of GCCI in preventing SWIs following cardiac surgery. However, some evidence does exist that such sponges can reduce the incidence of deep infections in high risk patients
Chang et al. [75], 2013 Systematic Review and Meta-analysis of Randomized Trials Fifteen randomised controlled trials involving 6979 patients Use of GCICI was associated with a significant decrease in SSI with an NNT of 21 p = 0.001;
Post hoc analysis showed that GCCI implants are effective in reducing SSI in sternotomy wounds. (OR = 0.59; 95% CI: 0.37–0.96;) (P = 0.03; NNT = 32)
Mavros et al. [76], 2012 Systematic Review and Meta-analysis of Randomized Trials Four RCTS involving 4672 patients GCCI reduced the risk of DSWI and need for surgical revision. No impact on SSWI or all cause mortality. Most commonly isolated pathogens were CoNS.
  1. Treatment Group = GCCI Group.
  2. RCT = Randomised Controlled Trial.
  3. NNT = Numbers Needed to Treat.
  4. SSWI = Superficial Sternal Wound Infection.
  5. DSWI = Deep Sternal Wound Infection.
  6. SSI = Surgical Site Infection.
  7. SWI = Sternal Wound Infection.
  8. CoNS = Coagulase Negative Staphylococcus Aureus.
  9. CABG = Coronary Artery Bypass Graft.
  10. BMI = Body Mass Index.
  11. RR = Relative Risk.
  12. OR = Odds Ratio.
  13. CI = Confidence Interval.