HEXI-PREP by Clinell Wipes

• Research type

  Research Study

• Full title

  An evaluation of the efficacy of HEXI PREP Skin versus placebo and ChloraPrep, for use in skin disinfection

• IRAS ID

  221842

• Contact name

  Daryl Bendel

• Contact email

  db0065@surrey.ac.uk

• Sponsor organisation

  GAMA Healthcare

• Eudract number

  2016-002692-98

• Duration of Study in the UK

  0 years, 3 months, 2 days

• Research summary

  To evaluate the skin antimicrobial properties of HEXI-PREP by Clinell Wipes in a GCP compliant, single centre, double-blind, within participant, randomised study versus (1) a placebo, negative control product (sterile saline 0.9%w/v) and (2) a positive control product, ChloraPrep (PL31760/004)as per the methodology specified by the US Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Pre-operative Skin Preparation.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  17/SC/0402

• Date of REC Opinion

  4 Oct 2017

• REC opinion

  Further Information Favourable Opinion