Phase 4
N=22
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01290978 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Drape Adhesion — 78.6; 181.3 grams-force
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ChloraPrep (Drug); DuraPrep (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drape Adhesion |
78.6; 181.3 | — |
| SECONDARY Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively |
0.67; 0.98; 0.31; 0.90; 0.30; 0.95 | — |
Summary
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Eligibility Criteria
Inclusion Criteria
- Subject is willing to sign the Research Consent form
- Healthy male or female subjects ages between 18 - 65
- Subject has agreed to be and appears to be compliant with requirements of the study
- Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
- Subject is willing to have the back clipped or shaved if it has excessive hair
Exclusion Criteria
- Sensitivity/allergy to adhesive products (e.g. medical tapes)
- Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
- Allergy to seafood
- History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
- Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
- History of diabetes
- Subject is currently pregnant or thinks she may be pregnant or is nursing
- Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy
- Subject is taking antihistamine medication
- Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study
- Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
Data sourced from ClinicalTrials.gov (NCT01290978). 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.