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Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

NCT00479193 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-09-11

No results posted yet for this study

Summary

Patients will be screened at the initial visit to the burn center. If the patients are eligible according to the inclusion/exclusion criteria, consent for the study will be obtained. One of the investigators will identify two sites that appear to be the same depth on each patient \[1 site Polymen and 1 site bacitracin/xeroform )\]. The depth of injury will be verified as partial thickness using laser doppler. Each site will be at least 4cm x 4cm in size. One site will be identified for bacitracin/xeroform and one site for Polymen. All burns will be initially debrided and cleaned according to burn unit protocol. The dressing will then be applied. All dressings will be covered with cotton gauze and ace wraps. Laser Doppler will be utilized to determine burn depth at both the trial and control sites. On each subsequent visit, patients will rate the pain of the dressing change on a 1-10 pain intensity scale. It will be noted if the wound appears infected or if antibiotics are prescribed.

The study will end for each patient when the investigator determines that 95% of their burn has re-epithelized.

Conditions

  • Burns

Interventions

DRUG

bacitracin/xeroform

single layer, change every 3 days

DRUG

Polymem

single layer of Polymen, change every 3 days

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Charles Yowler, MD · MetroHealth Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

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 NCT00479193 on ClinicalTrials.gov