Trial · NCT03385304
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
NCT03385304, Phase 4, Completed, University of Maryland, Baltimore; results first posted 2023-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures. Trials, record NCT03385304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03385304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
- NCT number
- NCT03385304
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,638 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Surgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture
- Interventions
- 10% povidone-iodine (1% free iodine) in purified water, 4% chlorhexidine gluconate (CHG) in purified water
- First posted
- 2017-12-28
- Last updated
- 2023-03-31
- Results first posted
- 2023-03-31
- Limitations and caveats
The uncontrolled use of adjunctive skin preparations before final antisepsis is a potential limitation of our study design. Although the use of a prewash with adjunctive alcohol was similarly distributed between the treatment groups, post-randomization confounding from this practice might exist. The trial has other limitations, including unmasked treatment allocation and the decision to initiate each recruitment site as soon as possible.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Within 30 days of the patient's last planned fracture management surgery | 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. |
| Primary | Number of Participants With a Deep Incisional or Organ/Space Infection | Within 90 days of the patient's last planned fracture management surgery | 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 |
| Secondary | Number of Participants With an Unplanned Fracture-Related Reoperation | Within 12 months of the patient's last planned operation | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Within 30 days of the patient's last planned fracture management surgery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Deep Incisional or Organ/Space Infection | Within 90 days of the patient's last planned fracture management surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Unplanned Fracture-Related Reoperation | Within 12 months of the patient's last planned operation | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 13 | Participants | ||
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 7 | Participants | ||
| Number of Participants With a Deep Incisional or Organ/Space Infection | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 46 | Participants | ||
| Number of Participants With a Deep Incisional or Organ/Space Infection | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 51 | Participants | ||
| Number of Participants With an Unplanned Fracture-Related Reoperation | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 118 | Participants | ||
| Number of Participants With an Unplanned Fracture-Related Reoperation | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 115 | Participants |
Source ClinicalTrials.gov
Participant flow38
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 828 | 7 |
| Overall Study | STARTED | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 810 | 7 |
| Overall Study | Months 1-2 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 114 | 7 |
| Overall Study | Months 1-2 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 108 | 7 |
| Overall Study | Months 3-4 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 102 | 7 |
| Overall Study | Months 3-4 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 104 | 7 |
| Overall Study | Months 5-6 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 98 | 7 |
| Overall Study | Months 5-6 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 53 | 5 |
| Overall Study | Months 7-8 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 50 | 5 |
| Overall Study | Months 7-8 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 68 | 7 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 178 | 828 | 178 |
| serious | Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 192 | 810 | 192 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 23 | 828 | 23 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 31 | 810 | 31 |
| serious | Neurological | Nervous system disorders | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 5 | 828 | 5 |
| serious | Neurological | Nervous system disorders | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 8 | 810 | 8 |
| serious | Renal | Renal and urinary disorders | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 10 | 828 | 10 |
| serious | Renal | Renal and urinary disorders | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 10 | 810 | 10 |
| serious | Cardiac | Cardiac disorders | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 7 | 828 | 7 |
| serious | Cardiac | Cardiac disorders | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 9 | 810 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 19 | 828 |
| Total, all-cause mortality | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 7 | 810 |
| Total, other adverse events | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 0 | 0 |
| Total, other adverse events | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 0 | 0 |
| Total, serious adverse events | 10% Povidone-iodine (1% Free Iodine) in Purified Water | 365 | 828 |
| Total, serious adverse events | 4% Chlorhexidine Gluconate (CHG) in Purified Water | 368 | 810 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: Number of Participants With an Unplanned Fracture-Related Reoperation | Trial comparisons |
| 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: Number of Participants With a Deep Incisional or Organ/Space Infection | Trial comparisons |
| 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: deaths from any cause | Trial comparisons |
| 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Trial comparisons |
| 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03385304
GET https://conductscience.org/api/trials/v1/NCT03385304/flow?page=2