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

Phase 1

• Conditions: For disinfection of the skin, immediately prior to invasive medical procedures; MedDRA version: 20.0Level: LLTClassification code 10065586Term: Skin disinfectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2016-002692-98-GB
• Lead Sponsor: GAMA Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified