Title |
A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection
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Published in |
BMC Infectious Diseases, August 2018
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DOI | 10.1186/s12879-018-3253-z |
Pubmed ID | |
Authors |
Ilker Uçkay, Benjamin Kressmann, Sarah Malacarne, Anna Toumanova, Jaafar Jaafar, Daniel Lew, Benjamin A. Lipsky |
Abstract |
An adjunctive topical therapy with gentamicin-sponges to systemic antibiotic therapy might improve the healing of infected diabetic foot ulcers (DFUI). Single-center, investigator-blinded pilot study, randomizing (1:1) the gentamicin-sponge with systemic antibiotic versus systemic antibiotics alone for patients with DFUI. We included 88 DFUI episodes with 43 patients in the gentamicin-sponge arm and 45 in the control arm. Overall, 64 (64/88; 73%) witnessed total clinical cure, 13 (15%) significant improvement, and 46 (52%) showed total eradication of all pathogens at the final visit. Regarding final clinical cure, there was no difference in favour of the gentamicin-sponges (26/45 vs. 31/43; p = 0.16). However, the gentamicin-sponge arm tended to a more rapid healing. In multivariate analysis adjusting for the case-mix, the variable "gentamicin-sponge" was not significantly associated with "cure and improvement". Gentamicin-sponges were very well tolerated, without any attributed adverse events. The gentamicin-sponge was very well tolerated, but did not significantly influence overall cure. ClinicalTrials.gov ( NCT01951768 ). Date 2 April 2013. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Ireland | 1 | 33% |
Venezuela, Bolivarian Republic of | 1 | 33% |
United States | 1 | 33% |
Demographic breakdown
Type | Count | As % |
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Scientists | 2 | 67% |
Members of the public | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 126 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 12 | 10% |
Student > Master | 9 | 7% |
Researcher | 7 | 6% |
Student > Postgraduate | 6 | 5% |
Student > Bachelor | 6 | 5% |
Other | 22 | 17% |
Unknown | 64 | 51% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 22 | 17% |
Nursing and Health Professions | 19 | 15% |
Pharmacology, Toxicology and Pharmaceutical Science | 6 | 5% |
Biochemistry, Genetics and Molecular Biology | 5 | 4% |
Engineering | 3 | 2% |
Other | 10 | 8% |
Unknown | 61 | 48% |