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NCT Number: NCT01341041

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 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.

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Key information

Conditions

Wound - in Medical Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chlorine dioxide

Biological

one time wash with 50ppm CD solution

Saline

Biological

one time wash with 50-100 cc normal saline

Primary outcomes

  1. cosmesis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Apr 25, 2011
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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