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Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group

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ClinicalTrials.gov Identifier: NCT00634166
Recruitment Status : Terminated (FDA request as study could not serve as the confirmatory trial.)
First Posted : March 12, 2008
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
Mylan Bertek Pharmaceuticals
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Burns
Interventions Drug: Sulfamylon® For 5 % Topical Solution
Drug: Topical Antimicrobial/Antifungal Medications
Enrollment 220
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description

Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Period Title: Overall Study
Started 82 138
Completed 22 78
Not Completed 60 60
Arm/Group Title Historical Control Prospective Patients/Active Drug Total
Hide Arm/Group Description

Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Total of all reporting groups
Overall Number of Baseline Participants 82 138 220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 138 participants 220 participants
38.9  (18.91) 44.7  (17.87) 42.6  (18.44)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 138 participants 220 participants
<18 years 11 5 16
>= 18 years 71 133 204
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 138 participants 220 participants
Female 19 29 48
Male 63 109 172
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 138 participants 220 participants
82 138 220
1.Primary Outcome
Title Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.
Hide Description [Not Specified]
Time Frame The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:

Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of Participants
4.9 4.3
2.Secondary Outcome
Title Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population
Hide Description All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
Time Frame Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
20.3 2.7
3.Secondary Outcome
Title Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population
Hide Description All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
Time Frame Days 18 to 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
4.5 6
4.Secondary Outcome
Title Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
Hide Description Treatment failure is defined as a change in topical antimicrobial therapy of initial meshed autograft due to suspected infection within the first 7 days or infectious graft loss.
Time Frame Days 5-7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
13.4 1.4
5.Secondary Outcome
Title Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Hide Description Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Time Frame Days 5-7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
2.4 0.7
6.Secondary Outcome
Title Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Hide Description Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Time Frame Days 12-14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
3.4 0.0
7.Secondary Outcome
Title Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Hide Description Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Time Frame Days 18-21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description:
.Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.

Sulfamylon® For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Overall Number of Participants Analyzed 82 138
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 1.3
Time Frame [Not Specified]
Adverse Event Reporting Description

There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error.

Reference -Table 14.1.3.1

 
Arm/Group Title Historical Control Prospective Patients/Active Drug
Hide Arm/Group Description

Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).

Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

All-Cause Mortality
Historical Control Prospective Patients/Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Historical Control Prospective Patients/Active Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/82 (10.98%)      27/138 (19.57%)    
Cardiac disorders     
Atrial Fibrillation   1/82 (1.22%)  1 2/138 (1.45%)  2
Bradycardia   1/82 (1.22%)  1 2/138 (1.45%)  2
Cardiac Arrest   0/82 (0.00%)  0 2/138 (1.45%)  2
Tachycardia   0/82 (0.00%)  0 2/138 (1.45%)  2
Gastrointestinal disorders     
Gastrointestinal Necrosis   0/82 (0.00%)  0 2/138 (1.45%)  2
General disorders     
Multi-organ Failure   0/82 (0.00%)  0 4/138 (2.90%)  4
Infections and infestations     
Pneumonia   1/82 (1.22%)  1 5/138 (3.62%)  5
Sepsis   2/82 (2.44%)  2 9/138 (6.52%)  12
Renal and urinary disorders     
Renal Failure   1/82 (1.22%)  1 6/138 (4.35%)  6
Renal Failure - acute   2/82 (2.44%)  2 4/138 (2.90%)  4
Respiratory, thoracic and mediastinal disorders     
Hypoxia   0/82 (0.00%)  0 3/138 (2.17%)  3
Pulmonary Embolism   0/82 (0.00%)  0 2/138 (1.45%)  2
Respiratory Acidosis   0/82 (0.00%)  0 2/138 (1.45%)  2
Respiratory Failure   0/82 (0.00%)  0 7/138 (5.07%)  8
Vascular disorders     
Deep Vein Thrombosis   0/82 (0.00%)  0 9/138 (6.52%)  9
Hypotension   1/82 (1.22%)  1 4/138 (2.90%)  4
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Historical Control Prospective Patients/Active Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/82 (90.24%)      130/138 (94.20%)    
Blood and lymphatic system disorders     
Anaemia   16/82 (19.51%)  20 27/138 (19.57%)  30
Coagulopathy   1/82 (1.22%)  1 7/138 (5.07%)  7
Leukocytosis   3/82 (3.66%)  3 12/138 (8.70%)  12
Thrombocythaemia   7/82 (8.54%)  8 14/138 (10.14%)  14
Thrombocytopenia   2/82 (2.44%)  2 7/138 (5.07%)  7
Cardiac disorders     
Atrial Fibrillation   1/82 (1.22%)  1 9/138 (6.52%)  9
Tachycardia   4/82 (4.88%)  4 20/138 (14.49%)  20
Gastrointestinal disorders     
Constipation   34/82 (41.46%)  42 42/138 (30.43%)  48
Diarrhea   2/82 (2.44%)  2 10/138 (7.25%)  11
Nausea   13/82 (15.85%)  13 18/138 (13.04%)  18
Vomiting   2/82 (2.44%)  2 8/138 (5.80%)  8
General disorders     
Pyrexia   12/82 (14.63%)  13 20/138 (14.49%)  35
Infections and infestations     
Bacteraemia   2/82 (2.44%)  2 10/138 (7.25%)  10
Cellulitis   3/82 (3.66%)  3 7/138 (5.07%)  7
Pneumonia   16/82 (19.51%)  17 19/138 (13.77%)  22
Sepsis   3/82 (3.66%)  3 11/138 (7.97%)  14
Urinary Tract Infection   7/82 (8.54%)  7 11/138 (7.97%)  13
Injury, poisoning and procedural complications     
Procedural Hypotension   0/82 (0.00%)  0 8/138 (5.80%)  17
Procedural Pain   5/82 (6.10%)  5 0/138 (0.00%)  0
Investigations     
Culture Wound Positive   5/82 (6.10%)  12 5/138 (3.62%)  9
Metabolism and nutrition disorders     
Hyperglycemia   4/82 (4.88%)  4 17/138 (12.32%)  17
Hypernatraemia   2/82 (2.44%)  2 10/138 (7.25%)  11
Hypocalcaemia   8/82 (9.76%)  8 9/138 (6.52%)  9
Hypoglycaemia   6/82 (7.32%)  7 9/138 (6.52%)  10
Hypokalaemia   8/82 (9.76%)  12 13/138 (9.42%)  14
Hypomagnesaemia   0/82 (0.00%)  0 7/138 (5.07%)  7
Hyponatraemia   3/82 (3.66%)  3 13/138 (9.42%)  14
Hypophosphataemia   8/82 (9.76%)  8 16/138 (11.59%)  17
Malnutrition   1/82 (1.22%)  1 7/138 (5.07%)  8
Psychiatric disorders     
Agitation   8/82 (9.76%)  8 19/138 (13.77%)  19
Anxiety   7/82 (8.54%)  7 15/138 (10.87%)  16
Depression   3/82 (3.66%)  3 8/138 (5.80%)  8
Insomnia   12/82 (14.63%)  12 23/138 (16.67%)  26
Renal and urinary disorders     
Renal Failure   2/82 (2.44%)  2 8/138 (5.80%)  8
Renal Failure-acute   3/82 (3.66%)  3 9/138 (6.52%)  9
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/82 (1.22%)  1 11/138 (7.97%)  14
Skin and subcutaneous tissue disorders     
Pruritus   12/82 (14.63%)  13 25/138 (18.12%)  28
Vascular disorders     
Deep Vein Thrombosis   0/82 (0.00%)  0 9/138 (6.52%)  9
Hypertension   4/82 (4.88%)  4 13/138 (9.42%)  13
Hypotension   5/82 (6.10%)  5 13/138 (9.42%)  27
Indicates events were collected by systematic assessment
The study was terminated on 17 June 2013 due to the recommendation and request by the FDA to design a superiority clinical study to satisfy the sponsor's post marketing study commitment for SS5%.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Principal Investigator shall provide Sponsor with (i) a copy of the papers prepared for publication by him or her as soon as possible, but in any event not less than sixty (60) days prior to their submission to a scientific journal or other publication; or (ii) a reasonably detailed summary or abstract of any oral presentation not less than forty-five (45) days prior to their submission or presentation. Sponsor may comment and remove any confidential information as needed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Davis, M.D.
Organization: Mylan Pharmaceuticals Inc.
Phone: 304.554.6503
EMail: eric.davis@mylan.com
Layout table for additonal information
Responsible Party: Viatris Inc. ( Mylan Inc. )
ClinicalTrials.gov Identifier: NCT00634166    
Other Study ID Numbers: SMS-401
First Submitted: February 11, 2008
First Posted: March 12, 2008
Results First Submitted: September 22, 2014
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2022