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Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks (Soaks)

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ClinicalTrials.gov Identifier: NCT00675922
Recruitment Status : Terminated (Data inconclusive.)
First Posted : May 12, 2008
Results First Posted : January 18, 2013
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Burn
Intervention Drug: Sulfamylon 5% and Silver Nitrate Soaks
Enrollment 98
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.
Arm/Group Title Sulfamylon Solution 5% and Silver Nitrate Soaks
Hide Arm/Group Description Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
Period Title: Overall Study
Started 98
Completed 98
Not Completed 0
Arm/Group Title Sulfamylon vs Silver Nitrate Solution
Hide Arm/Group Description Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
<=18 years
86
  87.8%
Between 18 and 65 years
12
  12.2%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
32
  32.7%
Male
66
  67.3%
1.Primary Outcome
Title Infection Rate
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections
Arm/Group Title Percent Infections:Sulfamylon Site Percent Infections: Silver Nitrate Site
Hide Arm/Group Description:
Percent of sites that developed infections with Sulfamylon soaks
Percent of sites that developed infections with Silver Nitrate soaks
Overall Number of Participants Analyzed 98 98
Measure Type: Number
Unit of Measure: percentage of participants
72 74
2.Secondary Outcome
Title Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients
Hide Description [Not Specified]
Time Frame Admission to burn unit to discharge
Outcome Measure Data Not Reported
Time Frame 1995-2008
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulfamylon Soaks, Silver Nitrate Soaks
Hide Arm/Group Description Patients receive both treatments and each treated site is compared.
All-Cause Mortality
Sulfamylon Soaks, Silver Nitrate Soaks
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sulfamylon Soaks, Silver Nitrate Soaks
Affected / at Risk (%) # Events
Total   9/98 (9.18%)    
Endocrine disorders   
hypoglycemia * [1]  2/98 (2.04%)  2
Infections and infestations   
Invasive infection, MOF, death  [2]  1/98 (1.02%)  1
Sepsis, multi organ failure and death  [3]  1/98 (1.02%)  1
Renal and urinary disorders   
renal failure, death  [4]  1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders   
Patient aspiration and death * [5]  1/98 (1.02%)  1
pneumothorax * [6]  1/98 (1.02%)  1
chest tube fell out * [7]  1/98 (1.02%)  1
Vascular disorders   
ischemia of leg * [8]  1/98 (1.02%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
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.
[2]
2001: 74% burn admitted with invasive infection, developed multi organ failure and expired. PI opinion is Adverse Event is unlikely related to study.
[3]
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.
[4]
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.
[5]
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.
[6]
2001: 70% burn patient, pneumothorax occured during subclavian IV line placement for surgery. PI opinion is Adverse Event is not related to study.
[7]
2001: 70% burn, chest tube fell out while patient was being moved. PI opinion, Adverse Event not related to study.
[8]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sulfamylon Soaks, Silver Nitrate Soaks
Affected / at Risk (%) # Events
Total   2/98 (2.04%)    
Skin and subcutaneous tissue disorders   
skin, opened wound * [1]  1/98 (1.02%)  1
open wound * [2]  1/98 (1.02%)  1
*
Indicates events were collected by non-systematic assessment
[1]
42% burn, patient fell and opened a wound in groin area. PI opinion, Adverse Event not related to study.
[2]
2003: 42% burn patient scratched biopsy site that had been sutured shut, opening a wound. PI opinion, Adverse Event not related to study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Herndon, MD
Organization: University of Texas Medical Branch
Phone: 409-770-6731
EMail: dherndon@utmb.edu
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00675922     History of Changes
Other Study ID Numbers: 95-096
First Submitted: December 26, 2007
First Posted: May 12, 2008
Results First Submitted: August 6, 2012
Results First Posted: January 18, 2013
Last Update Posted: October 4, 2018