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NCT01341041 · ClinicalTrials.gov registry record · Early Phase 1
Chlorine Dioxide Versus Saline for Wound Irrigation
A Early Phase 1 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 201
- Enrollment target
NCT01341041: Completed Early Phase 1 study, sponsored by Rhode Island Hospital.
NCT01341041 is a Early Phase 1 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 201 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (279% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01341041, a Early Phase 1 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 201 participants
- Enrollment target
Study Summary
This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.
Primary Outcome
Cosmesis will be assessed by taking pictures of the wound at presentation, upon receiving sutures, 48-72 hrs later, and 3-4 mths later. At 3-4 mths the patient will rate how well they think the wound healed, via a visual analog scale. At that time, two blinded ER physicians will do this as well. They will also designate a wound evaulation score, based on criteria that will be provided to them. Two blinded plastic surgeons will assess all photographs, visual analog scores. and wound evaluation sc
Interventions
- BIOLOGICAL chlorine dioxide
- BIOLOGICAL saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2004-08 |
| Est. Completion | 2009-06 |
| Phase | Early Phase 1 |
What the finished NCT01341041 record still lists
NCT01341041 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (279% higher).
The record links to 0 conditions, and to 2 interventions - of which chlorine dioxide is the first listed.
NCT01341041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01341041 about?
NCT01341041 is a clinical study titled "Chlorine Dioxide Versus Saline for Wound Irrigation". This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the h...
What is the current status of trial NCT01341041?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 201 participants. The study started on 2004-08. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01341041?
The interventions under investigation include: chlorine dioxide (BIOLOGICAL), saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT01341041?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01341041's enrollment target sits among peer trials
201 59th of 2000 higher than 1,942 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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