Trial Outcomes & Findings for Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures (NCT NCT03385304)
NCT ID: NCT03385304
Last Updated: 2023-03-31
Results Overview
Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following: 1. purulent drainage from the superficial incision. 2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment 3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat. 4. diagnosis of a superficial incisional SSI by the surgeon.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1638 participants
Primary outcome timeframe
Within 30 days of the patient's last planned fracture management surgery
Results posted on
2023-03-31
Participant Flow
Recruitment occurred between April 8, 2018, and June 8, 2021 at 14 hospitals in Canada, Spain and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 hours of the injury.
To ensure wide generalizability to routine practice, the protocol allowed prewashing of the operative extremity with alcohol or other antiseptics before performing the final skin antisepsis with the study solution. In addition to ensuring trial feasibility and protocol adherence, this decision pragmatically allowed the intact skin to receive mechanical scrubbing or partial alcohol antisepsis at the treating surgeon's discretion.
Unit of analysis: Clinical Sites
Participant milestones
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Overall Study
STARTED
|
828 7
|
810 7
|
|
Overall Study
Months 1-2
|
114 7
|
108 7
|
|
Overall Study
Months 3-4
|
102 7
|
104 7
|
|
Overall Study
Months 5-6
|
98 7
|
53 5
|
|
Overall Study
Months 7-8
|
50 5
|
68 7
|
|
Overall Study
Months 9-10
|
91 6
|
63 5
|
|
Overall Study
Months 11-12
|
72 5
|
75 5
|
|
Overall Study
Months 13-14
|
62 5
|
50 4
|
|
Overall Study
Months 15-16
|
38 4
|
55 5
|
|
Overall Study
Months 17-18
|
38 5
|
44 5
|
|
Overall Study
Months 19-20
|
32 5
|
46 3
|
|
Overall Study
Months 21-22
|
50 4
|
40 5
|
|
Overall Study
Months 23-24
|
30 4
|
64 5
|
|
Overall Study
Months 25-26
|
22 1
|
14 1
|
|
Overall Study
Months 27-28
|
21 1
|
18 1
|
|
Overall Study
Months 29-30
|
0 0
|
8 1
|
|
Overall Study
Months 31-32
|
8 1
|
0 0
|
|
Overall Study
COMPLETED
|
787 7
|
784 7
|
|
Overall Study
NOT COMPLETED
|
41 0
|
26 0
|
Reasons for withdrawal
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Overall Study
Death
|
19
|
7
|
|
Overall Study
Lost to Follow-up
|
17
|
14
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Incarceration
|
2
|
3
|
Baseline Characteristics
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Baseline characteristics by cohort
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
n=828 Participants
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
n=810 Participants
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
Total
n=1638 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
45.2 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 17.9 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
324 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
627 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
504 Participants
n=5 Participants
|
507 Participants
n=7 Participants
|
1011 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
665 Participants
n=5 Participants
|
624 Participants
n=7 Participants
|
1289 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
124 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Central or South American
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indigenous
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
Underweight (<18.5 kg/m^2)
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
BMI
Healthy weight (18.5 - 24.9 kg/m^2)
|
243 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
BMI
Overweight (25.0-29.9 kg/m^2)
|
247 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
518 Participants
n=5 Participants
|
|
BMI
Obesity (>30.0 kg/m^2)
|
329 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
658 Participants
n=5 Participants
|
|
Diabetes of any type
|
94 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Current smoker
|
293 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
567 Participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Physical Score
Class I or II
|
423 Participants
n=5 Participants
|
436 Participants
n=7 Participants
|
859 Participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Physical Score
Class III or higher
|
405 Participants
n=5 Participants
|
374 Participants
n=7 Participants
|
779 Participants
n=5 Participants
|
|
Number of included open fractures per participant
One
|
775 Participants
n=5 Participants
|
753 Participants
n=7 Participants
|
1528 Participants
n=5 Participants
|
|
Number of included open fractures per participant
Two
|
44 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Number of included open fractures per participant
Three
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of the patient's last planned fracture management surgeryGuided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following: 1. purulent drainage from the superficial incision. 2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment 3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat. 4. diagnosis of a superficial incisional SSI by the surgeon.
Outcome measures
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
n=787 Participants
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
n=784 Participants
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)
|
13 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Within 90 days of the patient's last planned fracture management surgeryGuided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017): Deep Incisional Infection: Occurs within 90 days post definitive fracture management; \& involves fascial/muscle layers; \& has at least one of the following: 1. deep incision purulent drainage 2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \& has at least one of the following: fever (\> 38 °C); localized pain or tenderness 3. other evidence of deep incision infection on anatomical exam or imaging test Organ/Space Infection: Occurs within 90 days post definitive fracture management; \& involves any part of the body deeper than the fascial/muscle layers; \& has at least one of the following: 1. organ/space purulent drainage 2. organisms in organ/space identified by microbiologic testing 3. other evidence of organ/space infection on anatomical exam or imaging test
Outcome measures
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
n=787 Participants
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
n=784 Participants
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Number of Participants With a Deep Incisional or Organ/Space Infection
|
46 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Within 12 months of the patient's last planned operationPopulation: Primary and secondary outcomes were evaluated using a complete case analysis. For that reason, the overall number of participants analyzed differs from the numbers provided under the Participant Flow module.
Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union.
Outcome measures
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
n=734 Participants
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
n=738 Participants
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Number of Participants With an Unplanned Fracture-Related Reoperation
|
118 Participants
|
115 Participants
|
Adverse Events
10% Povidone-iodine (1% Free Iodine) in Purified Water
Serious events: 365 serious events
Other events: 0 other events
Deaths: 19 deaths
4% Chlorhexidine Gluconate (CHG) in Purified Water
Serious events: 368 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
10% Povidone-iodine (1% Free Iodine) in Purified Water
n=828 participants at risk
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
4% Chlorhexidine Gluconate (CHG) in Purified Water
n=810 participants at risk
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Study Fracture Related Complication
|
21.5%
178/828 • Number of events 178 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
23.7%
192/810 • Number of events 192 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Musculoskeletal and connective tissue disorders
Non-Study Fracture Related Complication
|
2.8%
23/828 • Number of events 23 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
3.8%
31/810 • Number of events 31 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Nervous system disorders
Neurological
|
0.60%
5/828 • Number of events 5 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
0.99%
8/810 • Number of events 8 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Renal and urinary disorders
Renal
|
1.2%
10/828 • Number of events 10 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.2%
10/810 • Number of events 10 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Cardiac disorders
Cardiac
|
0.85%
7/828 • Number of events 7 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.1%
9/810 • Number of events 9 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Vascular disorders
Vascular
|
1.3%
11/828 • Number of events 11 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.5%
12/810 • Number of events 12 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Gastrointestinal disorders
Gastro-Intestinal
|
1.2%
10/828 • Number of events 10 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.5%
12/810 • Number of events 12 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.1%
26/828 • Number of events 26 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
3.1%
25/810 • Number of events 25 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
General disorders
Other
|
11.5%
95/828 • Number of events 95 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
8.5%
69/810 • Number of events 69 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
Other adverse events
Adverse event data not reported
Additional Information
Research Administrator
University of Maryland, Baltimore
Phone: 410-706-6823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place