An evaluation of the efficacy of HEXI-PREP by Clinell Wipes versus placebo and ChloraPrep, for use in pre-operative skin preparation

INTERVENTION: Product Name: HEXI‐PREP by Clinell Wipes Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Chlorhexidine Gluconate CAS Number: 18472‐51‐0 Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 2.0‐ INN or Proposed INN: Isopropyl Alcohol CAS Number: 67‐63‐0 Concentration unit: % (V/V) percent volume/volume Concentration type: equal Concentration number: 70‐ Pharmaceutical form of the placebo: Cutaneous solution Route of administration of the placebo: Cutaneous use Trade Name: ChloraPrep Product Name: ChloraPrep Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Chlorhexidine Gluconate CAS Number: 18472‐51‐0 Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 2.0‐ INN or Proposed INN: Isopropyl Alcohol CAS Number: 67‐63‐0 Concentration unit: % (V/V) percent volume/volume Concentration type: equal Concentration number: 70‐ CONDITION: For disinfection of the skin, immediately prior to invasive medical procedures ; MedDRA version: 20.0 Level: LLT Classification code 10065586 Term: Skin disinfection System Organ Class: 100000004865 Therapeutic area: Body processes [G] ‐ Microbiological Phenomena [G06] SECONDARY OUTCOME: ; Secondary end point(s): Secondary endpoint assessments will be based on persistence of a log10 reduction of the baseline bacterial counts at each of the three test sites over a period of up to 24 hours.; Further secondary endpoints relate to local tolerance of the administered preparations.; ; Timepoint(s) of evaluation of this end point: Persistence of a log10 reduction of the baseline bacterial counts will be conducted; at 30 minutes and 6 hours (inguinal test sites) and 6 and 24 hours (clavicular and median cubital region of arm) after application to the test site compared to placebo and ChloraPrep active control; PRIMARY OUTCOME: ; Main Objective: The overall trial objective is to evaluate the antimicrobial properties of HEXI‐PREP by Clinell Wipes versus (1) Placebo, negative control (sterile saline 0.9%w/v) and (2) a positive control product, ChloraPrep (Chlorhexidine Gluconate 2.0%w/v / Isopropyl Alcohol 70%v/v) as per the methodology specified by the US Food & Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation.; ; The primary objective of the study is to demonstrate superiority of HEXI‐PREP by Clinell Wipe vs placebo (negative control) in reducing immediate bacterial load 1‐10 minutes after administration to each respective test site.; ; Primary end point(s): The primary outcome measure will be based on a log10 reduction of the immediate baseline bacterial count at 1‐10 minutes compared to placebo control.; ; The co‐primary analysis will test the hypothesis that HEXI‐PREP by Clinell Wipe is superior to placebo at each of the three test sites within the ITT population at 1‐10; minutes after administration; ; Secondary Objective: Secondary objectives of the study are to demonstrate superiority of HEXI‐PREP by Clinell Wipe vs placebo (negative control) in terms of persistence of a reduction in bacterial load at time points from 30 minutes ‐ 24 hours.; Additionally, to assess the relative efficacy of HEXI‐PREP by Clinell Wipes to ChloraPrep (positive control) in regard to a reduction in bacterial load at 1‐10 minutes, and time periods 30 mins ‐ 24 hours after administration to the test sites.; A final secondary objective is to establish the safety profile (local tolerance) of the administered preparations.; ; Timepoint(s) of evaluation of this end point: The co‐primary analysis will test the hypothesis that HEXI‐PREP by Clinell Wipe is superior to placebo at each of the three test sites within the ITT population at 1‐10; minutes after administration; INCLUSION CRITERIA: 1. Male and female participants 18‐70 years, who have provided written informed consent to participate in the study. 2. Treatment sites with a bacterial baseline count greater or equal to 5 log10/cm(2) at the groin, and greater or equal to 3 log10/cm(2) at the clavicle and median cubital fossa of the arm of Day ‐5 of the study. 3. Participants, who in the opinion of the investigator, are in suitable health for inclusion in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240