Simple Hand Lacerations
Conditions
Keywords
wounds and lacerations, hand, infection, Antibiotics, antibacterial agents
Brief summary
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
Detailed description
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.
Interventions
DRUGcephalexin
500 mg (two 250 mg capsules) every 6 hours for 7 days
DRUGclindamycin
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
DRUGplacebo
Two placebo capsules every 6 hours for 7 days
Sponsors
Staten Island University Hospital
Kings County Hospital Center
State University of New York - Downstate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered hand lacerations. Simple or uncomplicated laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).
Exclusion criteria
* Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs) * Current or recent (within two weeks) use of any antibiotics * Allergy to clindamycin or cephalexin * Bites (e.g. dog, cat, or human) * Lacerations resulted from crush injury * Lacerations involving bone, tendon, blood vessel, or nerve * Lacerations inflicted more than 12 hours prior to ED visit * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Wound Infection | 2 weeks | Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Cepahlexin cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days | 24 |
| Placebo placebo: Two placebo capsules every 6 hours for 7 days | 24 |
| Total | 73 |
Baseline characteristics
| Characteristic | Clindamycin | Cepahlexin | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 20 Participants | 20 Participants | 63 Participants |
| Age, Continuous | 39 years | 42 years | 40 years | 41 years |
| Region of Enrollment United States | 25 participants | 24 participants | 24 participants | 73 participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 5 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 18 Participants | 19 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 25 | 1 / 24 | 1 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clindamycin | Number of Participants With Presence of Wound Infection | 0 participants |
| Cepahlexin | Number of Participants With Presence of Wound Infection | 0 participants |
| Placebo | Number of Participants With Presence of Wound Infection | 1 participants |