Trial Outcomes & Findings for Pre-operative Alcohol Skin Solutions in Fractured Extremities (NCT NCT03523962)
NCT ID: NCT03523962
Last Updated: 2024-10-04
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
8485 participants
Primary outcome timeframe
Within 30 days of the patient's last planned fracture management surgery
Results posted on
2024-10-04
Participant Flow
Recruitment occurred between August 21, 2018, and March 18, 2023 at 25 hospitals in the United States and Canada. Of these hospitals, 20 recruited patients with either open or closed fractures; 3 hospitals recruited patients with closed fractures only, and 2 recruited those with open fractures only.
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 |
Closed Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
|
Closed Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
|
Open Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
|---|---|---|---|---|
|
Closed Fractures
STARTED
|
2748 12
|
4037 11
|
0 0
|
0 0
|
|
Closed Fractures
Iodine Povacrylex
|
1405 12
|
1955 11
|
0 0
|
0 0
|
|
Closed Fractures
Chlorhexidine Gluconate
|
1343 12
|
2082 11
|
0 0
|
0 0
|
|
Closed Fractures
COMPLETED
|
2580 12
|
3897 11
|
0 0
|
0 0
|
|
Closed Fractures
NOT COMPLETED
|
168 0
|
140 0
|
0 0
|
0 0
|
|
Open Fractures
STARTED
|
0 0
|
0 0
|
987 11
|
713 11
|
|
Open Fractures
Iodine Povacrylex
|
0 0
|
0 0
|
503 11
|
351 11
|
|
Open Fractures
Chlorhexidine Gluconate
|
0 0
|
0 0
|
484 11
|
362 11
|
|
Open Fractures
COMPLETED
|
0 0
|
0 0
|
954 11
|
697 11
|
|
Open Fractures
NOT COMPLETED
|
0 0
|
0 0
|
33 0
|
16 0
|
Reasons for withdrawal
| Measure |
Closed Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
|
Closed Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
|
Open Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], was the commercial product used.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] was the product used.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
|---|---|---|---|---|
|
Closed Fractures
Death
|
86
|
71
|
0
|
0
|
|
Closed Fractures
Lost to Follow-up
|
62
|
36
|
0
|
0
|
|
Closed Fractures
Withdrawal by Subject
|
19
|
29
|
0
|
0
|
|
Closed Fractures
Incarceration
|
1
|
4
|
0
|
0
|
|
Open Fractures
Death
|
0
|
0
|
11
|
6
|
|
Open Fractures
Lost to Follow-up
|
0
|
0
|
15
|
8
|
|
Open Fractures
Withdrawal by Subject
|
0
|
0
|
6
|
2
|
|
Open Fractures
Incarceration
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pre-operative Alcohol Skin Solutions in Fractured Extremities
Baseline characteristics by cohort
| Measure |
Closed-Fracture Population Iodine Group
n=3360 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Closed-Fracture Population Chlorhexidine Group
n=3425 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open-Fracture Population Iodine Group
n=854 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Open-Fracture Population Chlorhexidine Group
n=846 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Total
n=8485 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 20.2 • n=99 Participants
|
53.6 years
STANDARD_DEVIATION 20.4 • n=107 Participants
|
45.0 years
STANDARD_DEVIATION 18.3 • n=206 Participants
|
44.2 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 19.3 • n=31 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
1730 Participants
n=99 Participants
|
1739 Participants
n=107 Participants
|
312 Participants
n=206 Participants
|
309 Participants
n=7 Participants
|
4090 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
1629 Participants
n=99 Participants
|
1686 Participants
n=107 Participants
|
542 Participants
n=206 Participants
|
537 Participants
n=7 Participants
|
4394 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Sex · Missing Data
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
170 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
463 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3190 Participants
n=99 Participants
|
3244 Participants
n=107 Participants
|
789 Participants
n=206 Participants
|
799 Participants
n=7 Participants
|
8022 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2652 Participants
n=99 Participants
|
2706 Participants
n=107 Participants
|
584 Participants
n=206 Participants
|
589 Participants
n=7 Participants
|
6531 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
501 Participants
n=99 Participants
|
480 Participants
n=107 Participants
|
227 Participants
n=206 Participants
|
214 Participants
n=7 Participants
|
1422 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
140 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
326 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Indigenous
|
27 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Central or South American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Missing Data
|
30 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
88 Participants
n=31 Participants
|
|
BMI
Underweight (<18.5 kg/m^2)
|
99 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
204 Participants
n=31 Participants
|
|
BMI
Healthy weight (18.5 - 24.9 kg/m^2)
|
1068 Participants
n=99 Participants
|
1106 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
250 Participants
n=7 Participants
|
2676 Participants
n=31 Participants
|
|
BMI
Overweight (25.0-29.9 kg/m^2)
|
1082 Participants
n=99 Participants
|
1024 Participants
n=107 Participants
|
279 Participants
n=206 Participants
|
294 Participants
n=7 Participants
|
2679 Participants
n=31 Participants
|
|
BMI
Obesity (>30.0 kg/m^2)
|
1111 Participants
n=99 Participants
|
1215 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
289 Participants
n=7 Participants
|
2926 Participants
n=31 Participants
|
|
Diabetes of any type
|
470 Participants
n=99 Participants
|
445 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
1059 Participants
n=31 Participants
|
|
Current smoker
|
753 Participants
n=99 Participants
|
722 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
282 Participants
n=7 Participants
|
2046 Participants
n=31 Participants
|
|
Injury Severity Score (ISS)
|
9.0 units on a scale
STANDARD_DEVIATION 6.2 • n=99 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 6.2 • n=107 Participants
|
13.4 units on a scale
STANDARD_DEVIATION 8.5 • n=206 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 8.0 • n=7 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 7.2 • n=31 Participants
|
|
American Society of Anesthesiologist (ASA) Physical Score
Class I or II
|
1760 Participants
n=99 Participants
|
1752 Participants
n=107 Participants
|
440 Participants
n=206 Participants
|
463 Participants
n=7 Participants
|
4415 Participants
n=31 Participants
|
|
American Society of Anesthesiologist (ASA) Physical Score
Class III or higher
|
1600 Participants
n=99 Participants
|
1673 Participants
n=107 Participants
|
414 Participants
n=206 Participants
|
383 Participants
n=7 Participants
|
4070 Participants
n=31 Participants
|
|
Number of included fractures per participant
One
|
3169 Participants
n=99 Participants
|
3240 Participants
n=107 Participants
|
782 Participants
n=206 Participants
|
771 Participants
n=7 Participants
|
7962 Participants
n=31 Participants
|
|
Number of included fractures per participant
Two
|
166 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
458 Participants
n=31 Participants
|
|
Number of included fractures per participant
Three
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of the patient's last planned fracture management surgeryPopulation: Outcome data for surgical-site infection were missing for 4.5% of the patients in the closed-fracture population and for 2.8% of those in the open-fracture population.
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.
Outcome measures
| Measure |
Closed-Fracture Population Iodine Group
n=3205 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Closed-Fracture Population Chlorhexidine Group
n=3272 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open-Fracture Population Iodine Group
n=825 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Open-Fracture Population Chlorhexidine Group
n=826 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
|---|---|---|---|---|
|
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)
|
20 Participants
|
27 Participants
|
6 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Within 90 days of the patient's last planned fracture management surgeryPopulation: Outcome data for surgical-site infection were missing for 4.5% of the patients in the closed-fracture population and for 2.8% of those in the open-fracture population.
Guided 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
Outcome measures
| Measure |
Closed-Fracture Population Iodine Group
n=3205 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Closed-Fracture Population Chlorhexidine Group
n=3272 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open-Fracture Population Iodine Group
n=825 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Open-Fracture Population Chlorhexidine Group
n=826 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
|---|---|---|---|---|
|
Number of Participants With a Deep Incisional Infection
|
29 Participants
|
54 Participants
|
21 Participants
|
20 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 |
Closed-Fracture Population Iodine Group
n=2982 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Closed-Fracture Population Chlorhexidine Group
n=3047 Participants
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open-Fracture Population Iodine Group
n=784 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Open-Fracture Population Chlorhexidine Group
n=785 Participants
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
|---|---|---|---|---|
|
Number of Participants With an Unplanned Fracture-Related Reoperation
|
164 Participants
|
179 Participants
|
126 Participants
|
114 Participants
|
Adverse Events
Closed-Fracture Population Iodine Group
Serious events: 1177 serious events
Other events: 0 other events
Deaths: 145 deaths
Closed-Fracture Population Chlorhexidine Group
Serious events: 1212 serious events
Other events: 0 other events
Deaths: 140 deaths
Open-Fracture Population Iodine Group
Serious events: 430 serious events
Other events: 0 other events
Deaths: 13 deaths
Open-Fracture Population Chlorhexidine Group
Serious events: 368 serious events
Other events: 0 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Closed-Fracture Population Iodine Group
n=3360 participants at risk
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Closed-Fracture Population Chlorhexidine Group
n=3425 participants at risk
The closed-fracture population consisted of adults (≥18 years old) who were undergoing surgical fixation of a closed lower-limb or pelvic fracture. We excluded patients who had a concurrent open fracture, had a medical contraindication to receive either trial intervention, or had a chronic or acute infection at or near the fracture site at the time of the index surgery.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
Open-Fracture Population Iodine Group
n=854 participants at risk
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.
|
Open-Fracture Population Chlorhexidine Group
n=846 participants at risk
The open-fracture population consisted of adults (≥18 years old) who had an open upper-limb or lower-limb fracture warranting surgical fixation. In addition, the patient's open fracture must have received surgical débridement within 72 hours after injury. We excluded patients with open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital.
The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Study Fracture Related Complication
|
10.3%
347/3360 • Number of events 347 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
10.5%
360/3425 • Number of events 360 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
23.2%
198/854 • Number of events 198 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
22.1%
187/846 • Number of events 187 • 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
|
0.98%
33/3360 • Number of events 33 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.1%
36/3425 • Number of events 36 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
4.7%
40/854 • Number of events 40 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
3.1%
26/846 • Number of events 26 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Nervous system disorders
Neurological
|
0.98%
33/3360 • Number of events 33 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
0.99%
34/3425 • Number of events 34 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
0.35%
3/854 • Number of events 3 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.2%
10/846 • Number of events 10 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Renal and urinary disorders
Renal
|
2.4%
81/3360 • Number of events 81 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.4%
82/3425 • Number of events 82 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.6%
22/854 • Number of events 22 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.9%
16/846 • Number of events 16 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Cardiac disorders
Cardiac
|
2.6%
88/3360 • Number of events 88 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.6%
90/3425 • Number of events 90 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.9%
16/854 • Number of events 16 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
0.71%
6/846 • Number of events 6 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Vascular disorders
Vascular
|
1.3%
43/3360 • Number of events 43 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.2%
41/3425 • Number of events 41 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.8%
15/854 • Number of events 15 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.4%
12/846 • 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
|
1.7%
58/3360 • Number of events 58 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
1.7%
59/3425 • Number of events 59 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.5%
21/854 • Number of events 21 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
0.83%
7/846 • Number of events 7 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.8%
93/3360 • Number of events 93 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.6%
90/3425 • Number of events 90 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
3.4%
29/854 • Number of events 29 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
2.5%
21/846 • Number of events 21 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
|
General disorders
Other
|
11.9%
401/3360 • Number of events 401 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
12.3%
420/3425 • Number of events 420 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
10.1%
86/854 • Number of events 86 • 1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
|
9.8%
83/846 • Number of events 83 • 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