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Randomized Controlled Trial
. 2023 May;20(5):1426-1435.
doi: 10.1111/iwj.13998. Epub 2022 Oct 28.

Delivery of topical gentamicin cream via platform wound device to reduce wound infection-A prospective, controlled, randomised, clinical study

Jennifer Cooley  1 , Noor Obaidi  2 , Victoria Diaz  2 , Kristin Anselmo  2 , Elof Eriksson  3 , Anders H Carlsson  2 , Rodney K Chan  2 , Kristo Nuutila  3
Affiliations
Randomized Controlled Trial

Delivery of topical gentamicin cream via platform wound device to reduce wound infection-A prospective, controlled, randomised, clinical study

Jennifer Cooley et al. Int Wound J. 2023 May.

Abstract

The platform wound device (PWD) is a wound coverage system that is designed to decrease wound infection rates by allowing for direct delivery of topical antibiotics and antimicrobials while creating a sealed, protective barrier around the area of injury. This study evaluated the safety and efficacy of the PWD as a protective dressing and a delivery system for topical antibiotics compared to the current standard of care (SoC). This was a multi-center, prospective, randomised, controlled clinical trial. The wounds were treated with the PWD with gentamicin cream or SoC dressings. The wounds were evaluated before the start of treatment and after 48-96 hours via clinical assessment, photographs, and qualitative bacterial swabs for bacterial analysis. The delivery of gentamicin via the PWD was safe and did not cause any adverse effects. The treatment decreased both inflammation and bacterial growth during the study period. No significant differences in the SoC were observed. The PWD is a transparent and impermeable polyurethane chamber that encloses and protects the injured area. The delivery of topical gentamicin via the PWD was safe and effective. Clinical assessment for infection found the PWD to be non-inferior to the current SoC treatment options.

Keywords: gentamicin cream; platform wound device; topical treatment; wound healing; wound infection.

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Conflict of interest statement

Dr. Eriksson is the founder and chief medical officer of Applied Tissue Technologies LLC (ATT). He has not participated in the evaluation or recording of the results or the formulation of the conclusions or summary. Dr. Nuutila used to be an employee of the ATT. All the other authors have no conflict of interest to declare in relation to the content of this article.

Figures

FIGURE 1
FIGURE 1
Different shapes of PWD, including circular, oblong, and large oblong. Lower images show PWD covering wounds during the treatment
FIGURE 2
FIGURE 2
Wound inflammatory characteristics. A‐E, Comparing the average presence of wound inflammation characteristics from baseline to follow‐up. F, Comparing the percentage of improvement in each characteristic after treatment in SOC and PWD groups
FIGURE 3
FIGURE 3
A, Comparing average bacterial growth scores at baseline and at follow‐up for the PWD group versus the SoC group. B, Comparing the average change in bacterial growth scores from baseline to follow‐up for the PWD group versus the SoC group. C, Sub‐analysis comparing average bacterial growth scores at baseline and at follow‐up for the PWD group versus the NPWT subgroup. D, Sub‐analysis comparing the average change in bacterial growth scores from baseline to follow‐up for PWD group versus NPWT subgroup
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