title: Molecular diagnostics and personalised medicine in wound care: assessment of outcomes.
abstract: OBJECTIVE
  This large, level A, retrospective cohort study set out to compare healing outcomes in three large cohorts of wound patients managed universally for bioburden: standard of care group, who were prescribed systemic antibiotics on the basis of empiric and traditional culture-based methodologies; treatment group 1, who were prescribed an improved selection of systemic antibiotics based on the results of molecular diagnostics; treatment group 2 who received personalised topical therapeutics (including antibiotics) based on the results of molecular diagnostics.
  
  
  METHODS
  Apart from the differences in diagnostic methods and antibiotic treatments described above, all three cohorts were subjected to the same biofilm-based wound care protocol, which included evaluation of the host and bioburden, frequent sharp debridement, use of wound dressings and comprehensive standard care (reperfusion therapy, nutritional support, offloading, compression and management of comorbidities).
  
  
  RESULTS
  In all, 1378 patients were recruited into the study. In the standard of care group 48.5% of patients (244/503) healed completely during the 7-month study period. This increased to 62.4% (298/479) in treatment group 1 and 90.4% (358/396) in treatment group 2. Cox proportional hazards analysis revealed the time to complete closure decreased by 26% in treatment group 1 (p<0.001) and 45.9% in treatment group 2 (p<0.001) compared with the standard of care group. Patients in treatment group 2 had >200% better odds of healing at any given time point compared with the other cohorts.
  
  
  CONCLUSIONS
  Implementation of personalised topical therapeutics guided by molecular diagnosis resulted in statistically and clinically significant improvements in outcome. The integration of molecular diagnostics and personalised medicine provides a directed and targeted approach to wound care.
  
  
  BACKGROUND
  SED and RDW are owners of PathoGenius Laboratories, a clinical diagnostic laboratory. SED and RDW are owners of Research and Testing Laboratory, which develops molecular diagnostics. CJ and JK are clinical advisors for PathoGenius. CJ and JK are owners of Southeastern Medical Compounding, Savannah, GA and Southeastern Medical Technologies, Savannah, GA.
authors.affiliation: Research and Testing Laboratory and Pathogenius Diagnostics, Lubbock, TX, USA. sdowd@pathogenresearch.org
authors.forename: S E
authors.initials: SE
authors.lastname: Dowd
authors.forename: R D
authors.initials: RD
authors.lastname: Wolcott
authors.forename: J
authors.initials: J
authors.lastname: Kennedy
authors.forename: C
authors.initials: C
authors.lastname: Jones
authors.forename: S B
authors.initials: SB
authors.lastname: Cox
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001424:Bacterial Infections / Q000382:microbiology* / Q000628:therapy*; D018441:Biofilms; D002648:Child; D002675:Child, Preschool; D003646:Debridement / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D057089:Pathology, Molecular / Q000379:methods*; D057285:Precision Medicine / Q000379:methods*; D014456:Ulcer / Q000382:microbiology; D014945:Wound Healing / Q000502:physiology; D014947:Wounds and Injuries / Q000382:microbiology* / Q000628:therapy*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents