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Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization

NCT01035944 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-07-01

Study results available
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Summary

The purpose of this study is to determine if the use of HemCon chitosan-based dressings is effective to facilitate safe, effective debridement of chronic wounds in the operating room and inpatient ward settings and to minimize bacterial re-colonization of wounds.

Conditions

  • Wound Debridement

Interventions

DEVICE

HemCon Dressings and HemCon ChitoGauze; chitosan-based.

Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.

DEVICE

Gauze and saline dressings.

Control for both settings will be gauze and saline dressings.

Sponsors & Collaborators

  • HemCon Medical Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Robert D. Galiano, M.D. · Northwestern Memorial Hospital, Division of Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01035944 on ClinicalTrials.gov