Burn
Conditions
Keywords
Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate
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.
Interventions
DRUGSulfamylon 5% and Silver Nitrate Soaks
Application of Sulfamylon and Silver Nitrate Solution to burn wound daily
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 90 Years
Healthy volunteers
No
Inclusion criteria
* Burn Injury requiring excisional therapy * Hospitalization required until wounds are closed
Exclusion criteria
* Known hypersensitivity to products * Outpatient treatment for burn injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients admitted to Burn ICU with acute burn injury were eligible for recruitment
Pre-assignment details
Patients consented were randomized to one or two of the treatment medications.
Participants by arm
| Arm | Count |
|---|---|
| Sulfamylon vs Silver Nitrate Solution Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area | 98 |
| Total | 98 |
Baseline characteristics
| Characteristic | Sulfamylon vs Silver Nitrate Solution |
|---|---|
| Age, Categorical <=18 years | 86 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 98 |
| serious Total, serious adverse events | 9 / 98 |
Outcome results
Primary
Infection Rate
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)
Population: Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Percent Infections:Sulfamylon Site | Infection Rate | 72 percentage of participants | 0.05 |
| Percent Infections: Silver Nitrate Site | Infection Rate | 74 percentage of participants | — |
Secondary
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.
Time frame: Admission to burn unit to discharge
Population: 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.