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NCT02160574
A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
Phase 1 trial testing ChloraPrep in Surgical Site Infection in 40 participants. Completed in 1 September 2014.
1 September 2014
Quick facts
| Lead sponsor | Zurex Pharma, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | double |
| Enrollment | 40 |
| Start date | 1 June 2014 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 September 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ChloraPrep — full drug profile →
- 0.1% Sodium Lauryl Sulfate — full drug profile →
- 0.9% Physiological Saline — full drug profile →
- ZuraPrep without IPA
Conditions studied
- Surgical Site Infection — all drugs for Surgical Site Infection →
Sponsor
Zurex Pharma, Inc. — full company profile →
Who can join
18 and older, any sex, with Surgical Site Infection. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Scoring Scale (0-7) for Visual Evaluation of Skin Condition
Time frame: 0-21 days post dose
Results from skin scores of ZuraPrep and ZuraPrep without IPA will be compared statistically, and both will be compared to the Positive Control (0.1% Sodium Lauryl Sulfate).
Sponsor's own description
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02160574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ChloraPrep
Trials testing the same drug.
- NCT03782103 — In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) · Phase 3 · completed
- NCT03523962 — Pre-operative Alcohol Skin Solutions in Fractured Extremities · Phase 4 · completed
- NCT03224299 — Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation · Phase 2 · completed
- NCT03155178 — In Vivo Preoperative Skin Preparation Persistence Evaluation · Phase 2 · completed
- NCT02831816 — Clinical Evaluation of Patient Preoperative Prep · Phase 3 · completed
Other recruiting trials for Surgical Site Infection
Currently open trials in the same condition.
- NCT07501897 — Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Followin · NA · recruiting
- NCT07311395 — Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section · NA · recruiting
- NCT06649890 — A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™ · NA · recruiting
- NCT07005635 — The Effects of Different Time Reminder On Surgical Hand Scrubing · NA · active not recruiting
- NCT07049614 — Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients · active not recruiting
Other Zurex Pharma, Inc. trials
Trials by the same sponsor.
- NCT04756804 — Perioperative Patient Skin Antiseptic Preparation Evaluation · Phase 3 · completed
- NCT03782103 — In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) · Phase 3 · completed
- NCT02831816 — Clinical Evaluation of Patient Preoperative Prep · Phase 3 · completed
- NCT02831998 — In-vivo Efficacy of Patient Preoperative Prep · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02160574 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zurex Pharma, Inc.
- Last refreshed: 24 October 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02160574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing