Trial Outcomes & Findings for Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks (NCT NCT00675922)

NCT ID: NCT00675922

Last Updated: 2023-06-22

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 98 participants
• Primary outcome timeframe: Acute hospitalization following burn injury: admission to discharge (1-20 weeks)
• Results posted on: 2023-06-22

Participant Flow

Patients admitted to Burn ICU with acute burn injury were eligible for recruitment

Patients consented were randomized to one or two of the treatment medications.

Participant milestones

Measure	Sulfamylon Solution 5% and Silver Nitrate Soaks Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
Overall Study STARTED	98
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Baseline characteristics by cohort

Measure	Sulfamylon vs Silver Nitrate Solution n=98 Participants Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
Age, Categorical <=18 years	86 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	66 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	Percent Infections:Sulfamylon Site n=98 Participants Percent of sites that developed infections with Sulfamylon soaks	Percent Infections: Silver Nitrate Site n=98 Participants Percent of sites that developed infections with Silver Nitrate soaks
Infection Rate	72 percentage of participants .05	74 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Sulfamylon Soaks, Silver Nitrate Soaks

Serious events: 9 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sulfamylon Soaks, Silver Nitrate Soaks n=98 participants at risk Patients receive both treatments and each treated site is compared.
Infections and infestations Invasive infection, MOF, death	1.0% 1/98 • Number of events 1 • 1995-2008
Vascular disorders ischemia of leg	1.0% 1/98 • Number of events 1 • 1995-2008
Renal and urinary disorders renal failure, death	1.0% 1/98 • Number of events 1 • 1995-2008
Respiratory, thoracic and mediastinal disorders Patient aspiration and death	1.0% 1/98 • Number of events 1 • 1995-2008
Respiratory, thoracic and mediastinal disorders pneumothorax	1.0% 1/98 • Number of events 1 • 1995-2008
Endocrine disorders hypoglycemia	2.0% 2/98 • Number of events 2 • 1995-2008
Infections and infestations Sepsis, multi organ failure and death	1.0% 1/98 • Number of events 1 • 1995-2008
Respiratory, thoracic and mediastinal disorders chest tube fell out	1.0% 1/98 • Number of events 1 • 1995-2008

Other adverse events

Measure	Sulfamylon Soaks, Silver Nitrate Soaks n=98 participants at risk Patients receive both treatments and each treated site is compared.
Skin and subcutaneous tissue disorders skin, opened wound	1.0% 1/98 • Number of events 1 • 1995-2008
Skin and subcutaneous tissue disorders open wound	1.0% 1/98 • Number of events 1 • 1995-2008

Additional Information

Tina Mack-Moshay, ClinicalTrials.gov Administrator

University of Texas Medical Branch

Phone: 409-266-6917

Email: tlmackmo@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place