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

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.