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Data inconclusive.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfamylon 5% and Silver Nitrate Soaks | Drug | Application of Sulfamylon and Silver Nitrate Solution to burn wound daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
Patients consented were randomized to one or two of the treatment medications.
Patients admitted to Burn ICU with acute burn injury were eligible for recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulfamylon Solution 5% and Silver Nitrate Soaks | Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulfamylon vs Silver Nitrate Solution | Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infection Rate | Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks. | Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections | Posted | Number | percentage of participants | Acute hospitalization following burn injury: admission to discharge (1-20 weeks) |
|
1995-2008
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulfamylon Soaks, Silver Nitrate Soaks | Patients receive both treatments and each treated site is compared. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive infection, MOF, death | Infections and infestations | Systematic Assessment | 2001: 74% burn admitted with invasive infection, developed multi organ failure and expired. PI opinion is Adverse Event is unlikely related to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin, opened wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 42% burn, patient fell and opened a wound in groin area. PI opinion, Adverse Event not related to study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Mack-Moshay, ClinicalTrials.gov Administrator | University of Texas Medical Branch | 409-266-6917 | tlmackmo@utmb.edu |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008272 | Mafenide |
| D012835 | Silver Nitrate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Admission to burn unit to discharge |
| Participants |
|
| Sex: Female, Male | Count of Participants | 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. | 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. | Posted | Admission to burn unit to discharge |
|
|
| 9 |
| 98 |
| 2 |
| 98 |
|
| ischemia of leg | Vascular disorders | Non-systematic Assessment | 2001: 80% burn patient, during Arterial IV line placement for surgery, right leg became ischemic. Anticoagulants given. Patient discharged without complications. PI opinion is Adverse Event is not related to study. |
|
| renal failure, death | Renal and urinary disorders | Systematic Assessment | 2001: 90% burn admitted with renal failure. After patient was 95% grafted and healed, renal failure worsened and patient expired. PI opinion is Adverse Event unlikely related to study. |
|
| Patient aspiration and death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2001: 62% burn after discharge, patient aspirated during the night Advanced Cardiac Life Support provided, patient expired. PI opinion is Adverse Event not related to study. |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2001: 70% burn patient, pneumothorax occured during subclavian IV line placement for surgery. PI opinion is Adverse Event is not related to study. |
|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment | 2001: 70% burn patient blood sugar decreased to 30 while on insulin drip. 2001: 70% burn patient blood glucose decreased to 35 while on insulin drip. PI opinion, Neither Adverse Event is related to study. |
|
| Sepsis, multi organ failure and death | Infections and infestations | Systematic Assessment | 2001: 85% burn admitted with invasive infections became septic, developed renal failure then multi organ failure. Patient removed from respiratory support and expired. PI opinion, Adverse Event is possibly related to study. |
|
| chest tube fell out | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2001: 70% burn, chest tube fell out while patient was being moved. PI opinion, Adverse Event not related to study. |
|
|
| open wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 2003: 42% burn patient scratched biopsy site that had been sutured shut, opening a wound. PI opinion, Adverse Event not related to study. |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009566 | Nitrates |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D007287 | Inorganic Chemicals |
| D018030 | Silver Compounds |