A Phase 2/3 interventional study of Sulfamylon 5% and Silver Nitrate Soaks in Burn, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 1 site in United States. Open to participants aged 1 Day to 90 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 2/3, Interventional, and Treatment
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 98 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Application of Sulfamylon and Silver Nitrate Solution to burn wound daily
Also known as: Sulfamylon, Silver Nitrate
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)
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
Patients admitted to Burn ICU with acute burn injury were eligible for recruitment
| Milestone | Sulfamylon Solution 5% and Silver Nitrate Soaks |
|---|---|
| Started | 98 |
| Completed | 98 |
| Not completed | 0 |
Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.
| percentage of participants | Percent Infections:Sulfamylon Site | Percent Infections: Silver Nitrate Site |
|---|---|---|
| Infection Rate | 72 ± .05 | 74 |
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.
No measurements were reported for this outcome.
Collected over 1995-2008. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sulfamylon Soaks, Silver Nitrate Soaks | — | 9/98 (9.2%) | 2/98 (2%) |
| Event | Sulfamylon Soaks, Silver Nitrate Soaks |
|---|---|
| hypoglycemiaEndocrine disorders | 2/98 |
| Invasive infection, MOF, deathInfections and infestations | 1/98 |
| ischemia of legVascular disorders | 1/98 |
| renal failure, deathRenal and urinary disorders | 1/98 |
| Patient aspiration and deathRespiratory, thoracic and mediastinal disorders | 1/98 |
| pneumothoraxRespiratory, thoracic and mediastinal disorders | 1/98 |
| Sepsis, multi organ failure and deathInfections and infestations | 1/98 |
| chest tube fell outRespiratory, thoracic and mediastinal disorders | 1/98 |
| Event | Sulfamylon Soaks, Silver Nitrate Soaks |
|---|---|
| skin, opened woundSkin and subcutaneous tissue disorders | 1/98 |
| open woundSkin and subcutaneous tissue disorders | 1/98 |
| Age, Categorical(Participants) | Sulfamylon vs Silver Nitrate Solution |
|---|---|
| <=18 years | 86 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Sulfamylon vs Silver Nitrate Solution |
|---|---|
| Female | 32 |
| Male | 66 |
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston