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Am J Surg. 2017 Jun;213(6):1003-1009. doi: 10.1016/j.amjsurg.2016.10.007. Epub 2016 Nov 18.

A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.

Author information

1
Duke Clinical Research Institute, Duke University, Durham, NC, USA. Electronic address: Elliott.Bennett-Guerrero@stonybrookmedicine.edu.
2
CRC of Jackson, Jackson, MS, USA.
3
The Ohio State University Medical Center, Columbus, OH, USA.
4
Cedars-Sinai Medical Center, Los Angeles, CA, USA.
5
Memorial Hermann Memorial City Medical Center, Houston, TX, USA.
6
Shoals Clinical Research Associates, LLC, Florence, AL, USA.
7
V.A. Boston Healthcare System, Boston University and Harvard Medical School, Boston, MA, USA.
8
Duke Clinical Research Institute, Duke University, Durham, NC, USA.
9
Dr. Reddy's Laboratories, Inc., Princeton, NJ, USA.
10
Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina.

Abstract

BACKGROUND:

SI is a significant medical problem. DFA-02 is an investigational bioresorbable modified release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL). A Phase 2a study, where the drug was applied during surgical incision closure, suggested safety and tolerability but was not designed to assess its efficacy.

STUDY DESIGN:

In a Phase 2b randomized, blinded trial patients undergoing abdominal, primarily colorectal, surgery were randomized (4:1:1) to one of three study arms: DFA-02, matching placebo gel, or standard of care (SOC) involving irrigation of the wound with normal saline. The DFA-02 and placebo gel groups received up to 20 mL of study drug inserted above the fascia during wound closure, and were treated in a double-blind manner; the SOC group was treated in a single-blind manner. The primary endpoint was SSI (adjudicated centrally by a blinded committee) through postoperative day 30.

RESULTS:

Overall, 445 subjects (intention-to-treat) were randomized at 35 centers with 425 subjects completing the study and being evaluable. There were 67 SSIs (15.8%): 64.2% superficial, 7.5% deep, and 28.4% organ space. The incidence of SSI was not statistically significantly different between the DFA-02 and the placebo gel/SOC arms combined, 42/287 = 14.6% vs 25/138 = 18.1% (p = 0.36), respectively. Rehospitalization within 30 days was also similar between study groups (DFA-02 28.6%, placebo gel 21.4%, SOC 27.3%).

CONCLUSION:

In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI.

SUMMARY:

Patients undergoing abdominal surgery were randomized to one of three study arms: DFA-02 gel consisting of both gentamicin and vancomycin, matching placebo gel, or standard of care (SOC). Of 425 patients completing the study at 35 sites the gentamicin/vancomycin gel was not associated with a significant reduction in SSI.

KEYWORDS:

Gentamicin; Surgical site infection; Topical; Vancomycin

PMID:
27989501
DOI:
10.1016/j.amjsurg.2016.10.007
[Indexed for MEDLINE]

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