A Phase 4 interventional study of 10% povidone-iodine (1% free iodine) in purified water and 4% chlorhexidine gluconate (CHG) in purified water in Surgical Site Infection, Unplanned Fracture-Related Reoperation and Open Appendicular Fracture, sponsored by University of Maryland, Baltimore. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.
The inclusion criteria are:
The exclusion criteria are:
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.).
Drug: 10% povidone-iodine (1% free iodine) in purified water · Drug: 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.).
Drug: 10% povidone-iodine (1% free iodine) in purified water · Drug: 4% chlorhexidine gluconate (CHG) 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.
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)
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.
Time frame: Within 30 days of the patient's last planned fracture management surgery
Number of Participants With a Deep Incisional or Organ/Space Infection
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 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
Time frame: Within 90 days of the patient's last planned fracture management surgery
Number of Participants With an Unplanned Fracture-Related Reoperation
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.
Time frame: Within 12 months of the patient's last planned operation
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.
| Milestone | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water |
|---|---|---|
| Started | 828 | 810 |
| Months 1-2 | 114 | 108 |
| Months 3-4 | 102 | 104 |
| Months 5-6 | 98 | 53 |
| Months 7-8 | 50 | 68 |
| Months 9-10 | 91 | 63 |
| Months 11-12 | 72 | 75 |
| Months 13-14 | 62 | 50 |
| Months 15-16 | 38 | 55 |
| Months 17-18 | 38 | 44 |
| Months 19-20 | 32 | 46 |
| Months 21-22 | 50 | 40 |
| Months 23-24 | 30 | 64 |
| Months 25-26 | 22 | 14 |
| Months 27-28 | 21 | 18 |
| Months 29-30 | 0 | 8 |
| Months 31-32 | 8 | 0 |
| Completed | 787 | 784 |
| Not completed | 41 | 26 |
| Withdrew: Death | 19 | 7 |
| Withdrew: Lost to follow-up | 17 | 14 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Incarceration | 2 | 3 |
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.
| Participants | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water |
|---|---|---|
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | 13 | 7 |
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 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
| Participants | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water |
|---|---|---|
| Number of Participants With a Deep Incisional or Organ/Space Infection | 46 | 51 |
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.
| Participants | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water |
|---|---|---|
| Number of Participants With an Unplanned Fracture-Related Reoperation | 118 | 115 |
Collected over 1 year post injury. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10% Povidone-iodine (1% Free Iodine) in Purified Water | 19/828 (2.3%) | 365/828 (44.1%) | — |
| 4% Chlorhexidine Gluconate (CHG) in Purified Water | 7/810 (0.9%) | 368/810 (45.4%) | — |
| Event | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water |
|---|---|---|
| Study Fracture Related ComplicationMusculoskeletal and connective tissue disorders | 178/828 | 192/810 |
| OtherGeneral disorders | 95/828 | 69/810 |
| Non-Study Fracture Related ComplicationMusculoskeletal and connective tissue disorders | 23/828 | 31/810 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 26/828 | 25/810 |
| VascularVascular disorders | 11/828 | 12/810 |
| Gastro-IntestinalGastrointestinal disorders | 10/828 | 12/810 |
| RenalRenal and urinary disorders | 10/828 | 10/810 |
| CardiacCardiac disorders | 7/828 | 9/810 |
| NeurologicalNervous system disorders | 5/828 | 8/810 |
| Age, Continuous(years) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Age | 45.2 ± 18.2 | 44.5 ± 17.9 | 44.9 ± 18.1 |
| Sex: Female, Male(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Female | 324 | 303 | 627 |
| Male | 504 | 507 | 1011 |
| Race/Ethnicity, Customized(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Race — White | 665 | 624 | 1289 |
| Race — Black | 124 | 137 | 261 |
| Race — Central or South American | 10 | 20 | 30 |
| Race — Asian | 8 | 10 | 18 |
| Race — Prefer not to answer | 7 | 11 | 18 |
| Race — Indigenous | 11 | 5 | 16 |
| Race — Multiracial | 3 | 2 | 5 |
| Race — Native Hawaiian or Pacific Islander | 0 | 1 | 1 |
| BMI(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Underweight (<18.5 kg/m^2) | 9 | 10 | 19 |
| Healthy weight (18.5 - 24.9 kg/m^2) | 243 | 200 | 443 |
| Overweight (25.0-29.9 kg/m^2) | 247 | 271 | 518 |
| Obesity (>30.0 kg/m^2) | 329 | 329 | 658 |
| Diabetes of any type(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Count of participants | 94 | 76 | 170 |
| Current smoker(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Count of participants | 293 | 274 | 567 |
| American Society of Anesthesiologist (ASA) Physical Score(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| Class I or II | 423 | 436 | 859 |
| Class III or higher | 405 | 374 | 779 |
| Number of included open fractures per participant(Participants) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 4% Chlorhexidine Gluconate (CHG) in Purified Water | Total |
|---|---|---|---|
| One | 775 | 753 | 1528 |
| Two | 44 | 51 | 95 |
| Three | 9 | 6 | 15 |
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University of Maryland, Baltimore