Chlorine Dioxide Versus Saline for Wound Irrigation

NCT ID: NCT01341041

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Wound - in Medical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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chlorine dioxide

2 arms

Group Type EXPERIMENTAL

chlorine dioxide

Intervention Type BIOLOGICAL

one time wash with 50ppm CD solution

saline

one time wash with 50-100cc of normal saline

Group Type ACTIVE_COMPARATOR

saline

Intervention Type BIOLOGICAL

one time wash with 50-100 cc normal saline

Interventions

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chlorine dioxide

one time wash with 50ppm CD solution

Intervention Type BIOLOGICAL

saline

one time wash with 50-100 cc normal saline

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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0334-03

Identifier Type: -

Identifier Source: org_study_id

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