Prophylaxis of graft infection with rifampicin-bonded Gelseal graft: 2-year follow-up of a prospective clinical trial. Italian Investigators Group.
Between March 1991 and June 1992, 600 patients were treated with mono-, bifemoral or iliofemoral arterial graft revascularization for occlusions and/or aneurysms. The patients were divided into two groups: group A (n = 296) received a Gelseal Vascutek graft immersed for 15 min before implant in a solution containing 1 mg/ml rifampicin; group B (n = 304) received an untreated Gelseal Vascutek graft. Both groups received perioperative antibiotic treatment with cephalosporins. Clinical follow-up was performed at 1, 6, 12 and 24 months after surgery to exclude signs of graft infection. Statistical analysis (X(2)) of pre-, intra- and postoperative risk factors showed both groups to be well matched. Among 600 patients treated, the 2-year follow-up showed 12 cases of graft infection (2.0%): five in group A (1.7%) and seven in group B (2.3%) (P = n.s.). All cases of graft infection originated in the groin and Staphylococcus aureus was isolated in 50% of cases. Statistical analysis (Mann-Whitney U test) showed a significant prevalence of lymphatic complications and immediate redo surgery in patients with graft infection. Of the 12 cases with infection, one was lost to follow-up, three were treated with total graft removal, six with partial graft removal and two with conservative therapy: there were no deaths. In spite of the relatively limited series and follow-up, no statistically significant difference emerged from the clinical use of vascular grafts pretreated with antibiotics.
D'Addato
M
M
Centre for the Study of Vascular Graft, University of Bologna, Policlinico S. Orsola, Bologna, Italy.
Curti
T
T
Freyrie
A
A
D000368:Aged; D000783:Aneurysm / Q000601:surgery*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001157:Arterial Occlusive Diseases / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D005780:Gelatin; D006801:Humans; D008297:Male; D008875:Middle Aged; D011093:Polyethylene Terephthalates / Q000627:therapeutic use; D011446:Prospective Studies; D016459:Prosthesis-Related Infections / Q000517:prevention & control*; D012293:Rifampin / Q000008:administration & dosage*
D000900:Anti-Bacterial Agents; D004337:Drug Carriers; D011093:Polyethylene Terephthalates; D005780:Gelatin; D012293:Rifampin