Chlorine Dioxide Versus Saline for Wound Irrigation

Wound - in Medical Care Clinical Trial

Official title:

Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341041
• Other study ID #: 0334-03
• Status: Completed
• Phase: Phase 0
• First received: April 11, 2011
• Last updated: April 21, 2011
• Start date: August 2004
• Est. completion date: June 2009

Study information

• Verified date: April 2011
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound - in Medical Care

Intervention

Biological:
• chlorine dioxide
one time wash with 50ppm CD solution
• saline
one time wash with 50-100 cc normal saline

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cosmesis	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.	72 hrs post-ED visit	Yes