Back to results

Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks (Soaks)

Primary Purpose

Burn

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sulfamylon 5% and Silver Nitrate Soaks

About this trial

This is an interventional treatment trial for Burn focused on measuring Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate

Eligibility Criteria

1 Day - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Burn Injury requiring excisional therapy
Hospitalization required until wounds are closed

Exclusion Criteria:

Known hypersensitivity to products
Outpatient treatment for burn injury

Sites / Locations

University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sulfamylon 5% and Silver Nitrate Soaks

Arm Description

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

Outcomes

Primary Outcome Measures

Infection Rate

Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.

Secondary Outcome Measures

Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients

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.

Full Information

NCT ID

NCT00675922

First Posted

December 26, 2007

Last Updated

June 15, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT00675922

Brief Title

Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Acronym

Soaks

Official Title

Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Data inconclusive.

Study Start Date

July 1995 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn

Keywords

Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulfamylon 5% and Silver Nitrate Soaks

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sulfamylon 5% and Silver Nitrate Soaks

Other Intervention Name(s)

Sulfamylon, Silver Nitrate

Intervention Description

Application of Sulfamylon and Silver Nitrate Solution to burn wound daily

Primary Outcome Measure Information:

Title

Infection Rate

Description

Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.

Time Frame

Acute hospitalization following burn injury: admission to discharge (1-20 weeks)

Secondary Outcome Measure Information:

Title

Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients

Description

Time Frame

Admission to burn unit to discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Burn Injury requiring excisional therapy Hospitalization required until wounds are closed Exclusion Criteria: Known hypersensitivity to products Outpatient treatment for burn injury

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David N Herndon, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

We'll reach out to this number within 24 hrs