NCT00675922

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
12.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

January 18, 2013

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

12.8 years

First QC Date

December 26, 2007

Results QC Date

August 6, 2012

Last Update Submit

June 15, 2023

Conditions

Burn

Keywords

BurnWoundsWound infectionTopical antimicrobialsCeriumDakinsSulfamylon SoaksSilver Nitrate

Outcome Measures

Primary Outcomes (1)

  • Infection Rate

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

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

Secondary Outcomes (1)

  • Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients

    Admission to burn unit to discharge

Study Arms (1)

Sulfamylon 5% and Silver Nitrate Soaks

EXPERIMENTAL

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

Drug: Sulfamylon 5% and Silver Nitrate Soaks

Interventions

Sulfamylon 5% and Silver Nitrate SoaksDRUG

Application of Sulfamylon and Silver Nitrate Solution to burn wound daily

Also known as: Sulfamylon, Silver Nitrate
Sulfamylon 5% and Silver Nitrate Soaks

Eligibility Criteria

Age1 Day - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity to products
  • Outpatient treatment for burn injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

BurnsWounds and InjuriesWound Infection

Interventions

MafenideSilver Nitrate

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsNitratesNitric AcidNitrogen CompoundsInorganic ChemicalsSilver Compounds

Results Point of Contact

Title
Tina Mack-Moshay, ClinicalTrials.gov Administrator
Organization
University of Texas Medical Branch
tlmackmo@utmb.edu
409-266-6917

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

May 12, 2008

Study Start

July 1, 1995

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 22, 2023

Results First Posted

January 18, 2013

Record last verified: 2023-06

Locations

US(1)