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recruitment issues
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The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).
Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic | Experimental | Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. [previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] |
|
| topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic | Active Comparator | Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline) | Drug | Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Surgical Site Infection (SSI) | Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagi Demian, MDDS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. [previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline): Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 |
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| topical irrigation with sterile normal saline (NS) | Drug | Fractures will be irrigated with sterile normal saline prior to closure. |
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| intravenous (IV) prophylactic antibiotic | Drug | All arms with receive standard parenteral (IV) prophylactic antibiotic. |
|
| FG001 | Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. topical irrigation with sterile normal saline (NS): Fractures will be irrigated with sterile normal saline prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. [previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline): Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. |
| BG001 | Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. topical irrigation with sterile normal saline (NS): Fractures will be irrigated with sterile normal saline prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Surgical Site Infection (SSI) | Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge. | Posted | Count of Participants | Participants | 8 weeks |
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8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. [previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline): Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic | Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. topical irrigation with sterile normal saline (NS): Fractures will be irrigated with sterile normal saline prior to closure. intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nagi Demian, MDDS | The University of Texas Health Science Center at Houston | (713) 500-5082 | Nagi.Demian@uth.tmc.edu |
| Apr 2, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D005839 | Gentamicins |
| D000077330 | Saline Solution |
| D018890 | Chemoprevention |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004358 | Drug Therapy |
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