Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Phase 2

Terminated

• Conditions: Burn
• Interventions: Drug: Sulfamylon 5% and Silver Nitrate Soaks

• Registration Number: NCT00675922
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Detailed Description

Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 2007-12-26
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-12
• Results First Submitted: 2012-08-06
• Results First Submitted QC: 2012-12-10
• Results First Posted: 2013-01-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Burn Injury requiring excisional therapy
• Hospitalization required until wounds are closed

Exclusion Criteria

• Known hypersensitivity to products
• Outpatient treatment for burn injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sulfamylon 5% and Silver Nitrate Soaks	Sulfamylon 5% and Silver Nitrate Soaks	Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization.

Primary Outcome Measures

Name	Time	Method
Infection Rate	Acute hospitalization following burn injury: admission to discharge (1-20 weeks)	Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients	Admission to burn unit to discharge	At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data for this outcome. Although peer-reviewed articles have been located that reference NCT00675922 it is not clear and verifiable (without access to the actual study-related data) what the results for this outcome.

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States