Chlorine Dioxide Versus Saline for Wound Irrigation

Early Phase 1

Completed

• Conditions: Wound - in Medical Care
• Interventions: Biological: chlorine dioxide; Biological: saline

• Registration Number: NCT01341041
• Lead Sponsor: Rhode Island Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2007-12
• Study Completion: 2009-06
• Status Verified: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-21
• Last Update Submitted: 2011-04-21
• Study First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• 18-100 years old
• simple laceration requiring irrigation & sutures
• patient has method of contact
• patient is willing to return to ED in 3-4 mths

Exclusion Criteria

• immunocompromised
• consult required for repair
• diabetic
• require antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorine dioxide	chlorine dioxide	2 arms
saline	saline	one time wash with 50-100cc of normal saline

Primary Outcome Measures

Name	Time	Method
cosmesis	72 hrs post-ED visit	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 scores, and provide their own visual analog scale assessment of how well each wound healed.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States