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Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group

NCT00634166 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-09-29

Study results available
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Summary

The primary objective is to compare the effectiveness of treatment with Sulfamylon® solution as the initial topical moist dressing over meshed autografts following the initial graft procedure on preventing graft loss in a prospective cohort of subjects versus a historical control group in a non-inferiority trial.

Conditions

  • Burns

Interventions

DRUG

Sulfamylon® For 5 % Topical Solution

Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

DRUG

Topical Antimicrobial/Antifungal Medications

'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.

Sponsors & Collaborators

  • Mylan Bertek Pharmaceuticals

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Davis, MD · Mylan Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-12-31
Completion
2014-04-30

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 NCT00634166 on ClinicalTrials.gov