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
Conditions
Interventions
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
C
Sponsors
GAMA Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Participants who are exposed to topical antimicrobial agents, including medicated soaps, shampoos or lotions, who use biocide treated pools or hot-tubs, use tanning beds or sunbathing during the 14-day pre-test conditioning period or during the test period. 2. Exposure of the test sites to strong detergents, solvents or other irritants during the 14-day pre-test conditioning period or during the test period. 3. Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period. 4. Known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine. 5. Female patients who are pregnant, become pregnant or are breast-feeding during the pre-test conditioning or during the test period. 6. Active skin rashes or breaks in the skin at the test site 7. Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site. 8. Showering or bathing after Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1) 9. Participation in another clinical trial within 90 days preceding randomisation 10. Any other medical condition, which in the Investigator's opinion, should preclude participation. 11. Unwillingness to fulfil the performance requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactDavid Fairlamb
ProTherax Ltd
Outcome results
None listed