Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery

Elliott Bennett-Guerrero, Theodore N. Pappas, Walter A. Koltun, James W. Fleshman, Min Lin, Jyotsna Garg, Daniel B. Mark, Jorge E. Marcet, Feza H. Remzi, Virgilio V. George, Kerstin Newland, G. R. Corey

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges. METHODS: In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments. RESULTS: The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups. CONCLUSIONS: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.).

Original languageEnglish (US)
Pages (from-to)1038-1049
Number of pages12
JournalNew England Journal of Medicine
Volume363
Issue number11
DOIs
StatePublished - Sep 9 2010

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Colorectal Surgery
Surgical Wound Infection
Porifera
Gentamicins
Collagen
Infection
Control Groups
Anti-Bacterial Agents
Surgical Sponges
Fascia
Ambulatory Surgical Procedures
Multicenter Studies
Signs and Symptoms
Hospital Emergency Service
Technology
Morbidity
Costs and Cost Analysis
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Bennett-Guerrero, E., Pappas, T. N., Koltun, W. A., Fleshman, J. W., Lin, M., Garg, J., ... Corey, G. R. (2010). Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. New England Journal of Medicine, 363(11), 1038-1049. https://doi.org/10.1056/NEJMoa1000837

Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. / Bennett-Guerrero, Elliott; Pappas, Theodore N.; Koltun, Walter A.; Fleshman, James W.; Lin, Min; Garg, Jyotsna; Mark, Daniel B.; Marcet, Jorge E.; Remzi, Feza H.; George, Virgilio V.; Newland, Kerstin; Corey, G. R.

In: New England Journal of Medicine, Vol. 363, No. 11, 09.09.2010, p. 1038-1049.

Research output: Contribution to journalArticle

Bennett-Guerrero, E, Pappas, TN, Koltun, WA, Fleshman, JW, Lin, M, Garg, J, Mark, DB, Marcet, JE, Remzi, FH, George, VV, Newland, K & Corey, GR 2010, 'Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery', New England Journal of Medicine, vol. 363, no. 11, pp. 1038-1049. https://doi.org/10.1056/NEJMoa1000837
Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J et al. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. New England Journal of Medicine. 2010 Sep 9;363(11):1038-1049. https://doi.org/10.1056/NEJMoa1000837
Bennett-Guerrero, Elliott ; Pappas, Theodore N. ; Koltun, Walter A. ; Fleshman, James W. ; Lin, Min ; Garg, Jyotsna ; Mark, Daniel B. ; Marcet, Jorge E. ; Remzi, Feza H. ; George, Virgilio V. ; Newland, Kerstin ; Corey, G. R. / Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. In: New England Journal of Medicine. 2010 ; Vol. 363, No. 11. pp. 1038-1049.
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abstract = "BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges. METHODS: In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments. RESULTS: The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0{\%}]) than in the control group (63 of 302 patients [20.9{\%}], P=0.01). Superficial surgical-site infection occurred in 20.3{\%} of patients in the sponge group and 13.6{\%} of patients in the control group (P=0.03), and deep surgical-site infection in 8.3{\%} and 6.0{\%} (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7{\%}, vs. 11.0{\%} in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0{\%} vs. 4.3{\%}, P=0.15). The frequency of adverse events did not differ significantly between the two groups. CONCLUSIONS: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.).",
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AU - Lin, Min

AU - Garg, Jyotsna

AU - Mark, Daniel B.

AU - Marcet, Jorge E.

AU - Remzi, Feza H.

AU - George, Virgilio V.

AU - Newland, Kerstin

AU - Corey, G. R.

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N2 - BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges. METHODS: In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments. RESULTS: The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups. CONCLUSIONS: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.).

AB - BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges. METHODS: In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments. RESULTS: The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups. CONCLUSIONS: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.).

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