Table 1.

A summary of important studies on the use of GCCI (Gentamycin 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.

Treatment Group = GCCI Group.

RCT = Randomised Controlled Trial.

NNT = Numbers Needed to Treat.

SSWI = Superficial Sternal Wound Infection.

DSWI = Deep Sternal Wound Infection.

SSI = Surgical Site Infection.

SWI = Sternal Wound Infection.

CoNS = Coagulase Negative Staphylococcus Aureus.

CABG = Coronary Artery Bypass Graft.

BMI = Body Mass Index.

RR = Relative Risk.

OR = Odds Ratio.

CI = Confidence Interval.