Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

Withdrawn before enrolling · Phase 1

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT00479193

Run by

MetroHealth Medical Center

People needed

0

Starts

2006-10-01

Expected to finish

2008-12-01

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age + to or greater than 18
• Superficial 2nd degree burns of the trunk and extremities which the evaluating investigator believes will heal within 21 days without the need for surgery.
• Burn injury is less than 48 hours old
• Patient is able to return to burn clinic for required follow-up.
• Burn is of sufficient size to permit the application of trial and control dressings
• Outpatient

You may not qualify if…

• Age under 18
• Burn injury over 48 hours old
• Deep burn not expected to heal within 21 days
• Extremely superficial burn expected to heal in less than 7 days.
• Infected burns
• Patient unable to return to clinic for required follow-up (i.e. will use visiting nurse or PCP for follow-up).
• Patient unable to give consent.
• Inpatient

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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