Phase 3 N=39 Randomized Single-blind Prevention

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02224625 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Grading Scale for Visual Evaluation of Skin Condition — 0; 0; 0; 0 Scores Ranging (0-7)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 2% CHG Cloth solution (Drug); Vehicle Cloth (Device); Active Comparator (Drug); Saline (Other); SLS (Other)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Medline Industries
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Grading Scale for Visual Evaluation of Skin Condition	0; 0; 0; 0; 0; 2.9	—

Summary

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Eligibility Criteria

Inclusion Criteria

Free of skin disorders
Signed consent

Exclusion Criteria

Allergies to latex
Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
severe illness
Pregnant (females)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02224625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.