title: A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.
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.
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC, USA. Electronic address: Elliott.Bennett-Guerrero@stonybrookmedicine.edu.
authors.forename: Elliott
authors.initials: E
authors.lastname: Bennett-Guerrero
authors.affiliation: CRC of Jackson, Jackson, MS, USA.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Berry
authors.affiliation: The Ohio State University Medical Center, Columbus, OH, USA.
authors.forename: Sergio D
authors.initials: SD
authors.lastname: Bergese
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Phillip R
authors.initials: PR
authors.lastname: Fleshner
authors.affiliation: Memorial Hermann Memorial City Medical Center, Houston, TX, USA.
authors.forename: Harold S
authors.initials: HS
authors.lastname: Minkowitz
authors.affiliation: Shoals Clinical Research Associates, LLC, Florence, AL, USA.
authors.forename: Alvaro M
authors.initials: AM
authors.lastname: Segura-Vasi
authors.affiliation: V.A. Boston Healthcare System, Boston University and Harvard Medical School, Boston, MA, USA.
authors.forename: Kamal M F
authors.initials: KMF
authors.lastname: Itani
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC, USA.
authors.forename: Karen W
authors.initials: KW
authors.lastname: Henderson
authors.affiliation: Dr. Reddy's Laboratories, Inc., Princeton, NJ, USA.
authors.forename: Felicia P
authors.initials: FP
authors.lastname: Rackowski
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC, USA.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Aberle
authors.affiliation: Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Stryjewski
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC, USA.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.affiliation: Dr. Reddy's Laboratories, Inc., Princeton, NJ, USA.
authors.forename: Kent S
authors.initials: KS
authors.lastname: Allenby
mesh_terms: D058107:Abdominal Wound Closure Techniques; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D005782:Gels; D005839:Gentamicins; D014640:Vancomycin
keywords: Gentamicin; Surgical site infection; Topical; Vancomycin