Chlorine Dioxide Versus Saline for Wound Irrigation

Lifespan

Status and phase: Completed; Early Phase 1

Conditions: Wound - in Medical Care

Treatments: Biological: chlorine dioxide; Biological: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01341041

0334-03

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups

chlorine dioxide

Experimental group

Description:

2 arms

Treatment:

Biological: chlorine dioxide

saline

Active Comparator group

Description:

one time wash with 50-100cc of normal saline

Treatment:

Biological: saline