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Uçkay I, Kressmann B, Di Tommaso S, et al. A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE Open Med. 2018;6:2050312118773950doi: 10.1177/2050312118773950.
Uçkay, I., Kressmann, B., Di Tommaso, S., Portela, M., Alwan, H., Vuagnat, H., Maître, S., Paoli, C., & Lipsky, B. A. (2018). A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE open medicine, 62050312118773950. https://doi.org/10.1177/2050312118773950
Uçkay, Ilker, et al. "A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection." SAGE open medicine vol. 6 (2018): 2050312118773950. doi: https://doi.org/10.1177/2050312118773950
Uçkay I, Kressmann B, Di Tommaso S, Portela M, Alwan H, Vuagnat H, Maître S, Paoli C, Lipsky BA. A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE Open Med. 2018 May 13;6:2050312118773950. doi: 10.1177/2050312118773950. eCollection 2018. PMID: 29785265; PMCID: PMC5954574.
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SAGE Open Med. 2018 May 13;6:2050312118773950. doi: 10.1177/2050312118773950. eCollection 2018.

A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection.

SAGE open medicine

Ilker Uçkay, Benjamin Kressmann, Sébastien Di Tommaso, Marina Portela, Heba Alwan, Hubert Vuagnat, Sophie Maître, Christophe Paoli, Benjamin A Lipsky

Affiliations

  1. Service of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
  2. Wound Care Team, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
  3. Service of Diabetology and Endocrinology, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
  4. Podiatric School, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
  5. Division of Medical Sciences, Green Templeton College, University of Oxford, Oxford, UK.

PMID: 29785265 PMCID: PMC5954574 DOI: 10.1177/2050312118773950

Abstract

OBJECTIVES: The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings.

METHODS: To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin-collagen sponge with local care versus local care alone. Systemic antibiotic agents were prohibited.

RESULTS: We enrolled a total of 22 patients, 11 in the gentamicin-collagen sponge arm and 11 in the control arm. Overall, at end of therapy, 20 (91%) patients were categorized as achieving clinical cure of infection, and 2 (9%) as significant improvement. At the final study visit, only 12 (56%) of all patients achieved microbiological eradication of all pathogens. There was no difference in either clinical or microbiological outcomes in those who did or did not receive the gentamicin-collagen sponge, which was very well tolerated.

CONCLUSION: The results of this pilot trial suggest that topical antibiotic therapy with gentamicin-collagen sponge, although very well tolerated, does not appear to improve outcomes in mild diabetic foot ulcer infection.

Keywords: Gentamicin–collagen sponge; adverse drug events; antimicrobial safety; mild diabetic foot infections; topical antimicrobial therapy; wound infection; wound outcome

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

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