Effects of Therapy With Sulfamylon® 5% Topical Solution C... | NCT00634166

NCT00634166

Status Module

Sponsor/Collaborators Module

Name	Class
Mylan Bertek Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Historical Control	Other	Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms. These are considered the Topical Antimicrobial/Antifungal Medications	Drug: Topical Antimicrobial/Antifungal Medications
Prospective Patients/Active Drug	Experimental	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.	Drug: Sulfamylon® For 5 % Topical Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sulfamylon® For 5 % Topical Solution	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.		The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population	All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.	Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14
Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In order for prospective subjects to be eligible for entry into the study:

Subjects must have thermal injuries of 20-60% TBSA requiring at least one meshed autograft on the chest, abdomen, or proximal upper and lower extremities following surgical excision of the burn injury. Refer to Supplement 20.3.2: Lund Browder charts
Subjects may be male or female, 3 months of age or older
Females of childbearing potential must have a negative urine pregnancy test upon admission and agree to avoid pregnancy throughout the course of the study. Since this population is hospitalized for the duration of the study, an agreement of sexual abstinence is appropriate for this trial. Those subjects who do not wish to commit to sexual abstinence for the duration of this study must agree to avoid pregnancy by using a medically supervised method of contraception (such as hormonal contraception in conjunction with a vaginal spermicide or a tubal ligation at least 3 months prior to study entry)
Subjects must be willing and able to provide written informed consent. If subjects are unable to provide written informed consent, then the subject's legally acceptable representative may provide written informed consent in accordance with the IRB/IEC, and federal, state and local regulations.

Exclusion Criteria:

Prospective subjects will be excluded from the study for the following reasons:

Non-thermal burn injuries
Inhalation injuries resulting in a PaO2 /FIO2 ratio < 300 mmHg on more than one arterial blood gas in the first 48 hours post-admission
Females who are currently pregnant or breast feeding, or who intend to become pregnant during the course of the study
Subjects with acute renal failure
Subjects with known systemic allergy to sulfonamides or to sulfur-containing medication
Time interval between burn injury and excision and grafting is greater than 7 days
Grafting procedures that are conducted and/or evaluated on an outpatient basis
Inability to use a meshed autograft as part of the initial grafting procedure
Inability to use SS5% as the only initial prophylactic topical antimicrobial therapy on meshed autografts
Thermal burn injuries less than 20% or greater than 60% TBSA
Subjects who are participating in any other clinical studies involving any investigational product, or who have participated in such a study within the previous 30 days
Subjects with known glucose-6-phosphate dehydrogenase deficiency

Contacts/Locations Module

Name	Affiliation	Role
Eric Davis, MD	Mylan Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Medical Center		Mobile	Alabama	36617	United States
Arrowhead Regional Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Historical Control	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Prospective Patients/Active Drug

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Historical Control	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.
BG001	Prospective Patients/Active Drug	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00082 BG001138 BG002220

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.9± 18.91 BG00144.7± 17.87 BG00242.6± 18.44

Age, Customized

Number

participants

Title

Denominators

Categories

<18 years

Title	Measurements
	BG00011 BG0015 BG002

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00019 BG00129 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00082 BG001138 BG002

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

Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.

Posted

Number

Percentage of Participants

The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.

ID	Title	Description
OG000	Historical Control	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.
OG001	Prospective Patients/Active Drug	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.

Units	Counts
Participants	OG00082 OG001138

Title

Denominators

Categories

Title	Measurements
	OG0004.9 OG0014.3

Secondary

Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population

All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.

Posted

Number

Percentage of participants

Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Secondary

Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population

All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.

Posted

Number

Percentage of participants

Days 18 to 21

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Secondary

Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population

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.

Posted

Number

Percentage of participants

Days 5-7

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Secondary

Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population

Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.

Posted

Number

Percentage of participants

Days 5-7

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Secondary

Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population

Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.

Posted

Number

Percentage of participants

Days 12-14

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Secondary

Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population

Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.

Posted

Number

Percentage of participants

Days 18-21

ID	Title	Description
OG000	Historical Control	.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.
OG001	Prospective Patients/Active Drug	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Historical Control	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.			9	82	74	82
EG001	Prospective Patients/Active Drug	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.			27	138	130	138

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0012 events2 affected138 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0012 events2 affected138 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected138 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected138 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected138 at risk
Multi-organ Failure	General disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0014 events4 affected138 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected82 at risk EG0015 events5 affected138 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0002 events2 affected82 at risk EG00112 events9 affected138 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0016 events6 affected138 at risk
Renal Failure - acute	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG0014 events4 affected138 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0013 events3 affected138 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected138 at risk
Respiratory Acidosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected138 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0018 events7 affected138 at risk
Deep Vein Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0019 events9 affected138 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0014 events4 affected138 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00020 events16 affected82 at risk EG00130 events27 affected138 at risk
Coagulopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0017 events7 affected138 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected82 at risk EG00112 events12 affected138 at risk
Thrombocythaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0008 events7 affected82 at risk EG00114 events14 affected138 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG0017 events7 affected138 at risk
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0019 events9 affected138 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected82 at risk EG00120 events20 affected138 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00042 events34 affected82 at risk EG00148 events42 affected138 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG00111 events10 affected138 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00013 events13 affected82 at risk EG00118 events18 affected138 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG0018 events8 affected138 at risk
Pyrexia	General disorders	Systematic Assessment	EG00013 events12 affected82 at risk EG00135 events20 affected138 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0002 events2 affected82 at risk EG00110 events10 affected138 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected82 at risk EG0017 events7 affected138 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG00017 events16 affected82 at risk EG00122 events19 affected138 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0003 events3 affected82 at risk EG00114 events11 affected138 at risk
Urinary Tract Infection	Infections and infestations	Systematic Assessment	EG0007 events7 affected82 at risk EG00113 events11 affected138 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected82 at risk EG00117 events8 affected138 at risk
Procedural Pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected82 at risk EG0010 events0 affected138 at risk
Culture Wound Positive	Investigations	Systematic Assessment	EG00012 events5 affected82 at risk EG0019 events5 affected138 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected82 at risk EG00117 events17 affected138 at risk
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG00111 events10 affected138 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events8 affected82 at risk EG0019 events9 affected138 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0007 events6 affected82 at risk EG00110 events9 affected138 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00012 events8 affected82 at risk EG00114 events13 affected138 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0017 events7 affected138 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected82 at risk EG00114 events13 affected138 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events8 affected82 at risk EG00117 events16 affected138 at risk
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG0018 events7 affected138 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0008 events8 affected82 at risk EG00119 events19 affected138 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0007 events7 affected82 at risk EG00116 events15 affected138 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected82 at risk EG0018 events8 affected138 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00012 events12 affected82 at risk EG00126 events23 affected138 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected82 at risk EG0018 events8 affected138 at risk
Renal Failure-acute	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected82 at risk EG0019 events9 affected138 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected82 at risk EG00114 events11 affected138 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00013 events12 affected82 at risk EG00128 events25 affected138 at risk
Deep Vein Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected82 at risk EG0019 events9 affected138 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0004 events4 affected82 at risk EG00113 events13 affected138 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0005 events5 affected82 at risk EG00127 events13 affected138 at risk

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

ID	Term
D002056	Burns

ID	Term
D008272	Mafenide
D012996	Solutions
D000890	Anti-Infective Agents
D001414	Bacitracin
D000666	Amphotericin B

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D018942	Macrolides
D061065	Polyketides
D007783	Lactones

Units	Counts
Participants	OG00082 OG001138