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| Name | Class |
|---|---|
| Staten Island University Hospital | OTHER |
| Kings County Hospital Center | OTHER |
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Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clindamycin | Active Comparator | clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days |
|
| cepahlexin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cephalexin | Drug | 500 mg (two 250 mg capsules) every 6 hours for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of Wound Infection | Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| shahriar zehtabchi, MD | State University of New York - Downstate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings County Hospital Center | Brooklyn | New York | 11203 | United States | ||
| State University of New York, Downstate Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindamycin | clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days |
| FG001 | Cepahlexin | cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days |
| FG002 | Placebo | placebo: Two placebo capsules every 6 hours for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The median age of the subjects was 40 years (quartiles: 29, 53), and 71% were male (n=52).
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| ID | Title | Description |
|---|---|---|
| BG000 | Clindamycin | clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days |
| BG001 | Cepahlexin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Presence of Wound Infection | Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection. | Posted | Number | participants | 2 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 | Clindamycin | clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shahriar Zehtabchi | SUNY Downstate Medical Center | 718-245-2973 | shahriar.zehtabchi@downstate.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D022125 | Lacerations |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| clindamycin |
| Drug |
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days |
|
| placebo | Drug | Two placebo capsules every 6 hours for 7 days |
|
| Brooklyn |
| New York |
| 11203 |
| United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
| BG002 | Placebo | placebo: Two placebo capsules every 6 hours for 7 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo: Two placebo capsules every 6 hours for 7 days |
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Cepahlexin | cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days | 0 | 24 | 1 | 24 |
| EG002 | Placebo | placebo: Two placebo capsules every 6 hours for 7 days | 0 | 24 | 1 | 24 |
| dizziness | Nervous system disorders | Systematic Assessment |
|
| palpitation | Cardiac disorders | Systematic Assessment |
|
| Metal After-taste in th mouth | Gastrointestinal disorders | Systematic Assessment |
|
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |