Trial · NCT03523962
Pre-operative Alcohol Skin Solutions in Fractured Extremities
NCT03523962, Phase 4, Completed, University of Maryland, Baltimore; results first posted 2024-10-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pre-operative Alcohol Skin Solutions in Fractured Extremities. Trials, record NCT03523962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03523962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pre-operative Alcohol Skin Solutions in Fractured Extremities
- NCT number
- NCT03523962
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 8,485 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Surgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture, Closed Lower Extremity Fracture, Pelvic Fracture
- Interventions
- DuraPrep, ChloraPrep
- First posted
- 2018-05-14
- Last updated
- 2024-10-04
- Results first posted
- 2024-10-04
- Limitations and caveats
1. The patients and their surgeons were aware of the trial-group assignments.~2. The trial was limited to patients undergoing surgery for a fracture, so the generalizability of these findings to other surgical populations is unknown.
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 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 |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Deep Incisional Infection | Within 90 days of the patient's last planned fracture management surgery | 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. | 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 group12
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) | Closed-Fracture Population Iodine Group | 20 | Participants | ||
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Closed-Fracture Population Chlorhexidine Group | 27 | Participants | ||
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Open-Fracture Population Iodine Group | 6 | Participants | ||
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Open-Fracture Population Chlorhexidine Group | 9 | Participants | ||
| Number of Participants With a Deep Incisional Infection | Closed-Fracture Population Iodine Group | 29 | Participants | ||
| Number of Participants With a Deep Incisional Infection | Closed-Fracture Population Chlorhexidine Group | 54 | Participants | ||
| Number of Participants With a Deep Incisional Infection | Open-Fracture Population Iodine Group | 21 | Participants | ||
| Number of Participants With a Deep Incisional Infection | Open-Fracture Population Chlorhexidine Group | 20 | Participants | ||
| Number of Participants With an Unplanned Fracture-Related Reoperation | Closed-Fracture Population Iodine Group | 164 | Participants | ||
| Number of Participants With an Unplanned Fracture-Related Reoperation | Closed-Fracture Population Chlorhexidine Group | 179 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Closed Fractures | STARTED | Closed Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate | 2,748 | 12 |
| Closed Fractures | STARTED | Closed Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex | 4,037 | 11 |
| Closed Fractures | STARTED | Open Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate | 0 | 0 |
| Closed Fractures | STARTED | Open Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex | 0 | 0 |
| Closed Fractures | Iodine Povacrylex | Closed Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate | 1,405 | 12 |
| Closed Fractures | Iodine Povacrylex | Closed Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex | 1,955 | 11 |
| Closed Fractures | Iodine Povacrylex | Open Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate | 0 | 0 |
| Closed Fractures | Iodine Povacrylex | Open Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex | 0 | 0 |
| Closed Fractures | Chlorhexidine Gluconate | Closed Fractures - Iodine Povacrylex First, Then Chlorhexidine Gluconate | 1,343 | 12 |
| Closed Fractures | Chlorhexidine Gluconate | Closed Fractures - Chlorhexidine Gluconate First, Then Iodine Povacrylex | 2,082 | 11 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events36
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 | Closed-Fracture Population Iodine Group | 347 | 3,360 | 347 |
| serious | Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Closed-Fracture Population Chlorhexidine Group | 360 | 3,425 | 360 |
| serious | Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Open-Fracture Population Iodine Group | 198 | 854 | 198 |
| serious | Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Open-Fracture Population Chlorhexidine Group | 187 | 846 | 187 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Closed-Fracture Population Iodine Group | 33 | 3,360 | 33 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Closed-Fracture Population Chlorhexidine Group | 36 | 3,425 | 36 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Open-Fracture Population Iodine Group | 40 | 854 | 40 |
| serious | Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Open-Fracture Population Chlorhexidine Group | 26 | 846 | 26 |
| serious | Neurological | Nervous system disorders | Closed-Fracture Population Iodine Group | 33 | 3,360 | 33 |
| serious | Neurological | Nervous system disorders | Closed-Fracture Population Chlorhexidine Group | 34 | 3,425 | 34 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Closed-Fracture Population Iodine Group | 145 | 3,360 |
| Total, all-cause mortality | Closed-Fracture Population Chlorhexidine Group | 140 | 3,425 |
| Total, all-cause mortality | Open-Fracture Population Iodine Group | 13 | 854 |
| Total, all-cause mortality | Open-Fracture Population Chlorhexidine Group | 13 | 846 |
| Total, other adverse events | Closed-Fracture Population Iodine Group | 0 | 0 |
| Total, other adverse events | Closed-Fracture Population Chlorhexidine Group | 0 | 0 |
| Total, other adverse events | Open-Fracture Population Iodine Group | 0 | 0 |
| Total, other adverse events | Open-Fracture Population Chlorhexidine Group | 0 | 0 |
| Total, serious adverse events | Closed-Fracture Population Iodine Group | 1,177 | 3,360 |
| Total, serious adverse events | Closed-Fracture Population Chlorhexidine Group | 1,212 | 3,425 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03523962
GET https://conductscience.org/api/trials/v1/NCT03523962/flow?page=2