Simple Hand LacerationsNCT01155154
Antibiotic Prophylaxis for Simple Hand Lacerations
A study testing cephalexin and clindamycin in people with Simple Hand Lacerations, run by State University of New York - Downstate Medical Center at 3 sites in United States.
Trial summary
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simple Hand Lacerations
- What is being tested?
- cephalexin and clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kings County Hospital Center
Brooklyn, New York, 11203
State University of New York, Downstate Medical Center
Brooklyn, New York, 11203
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
Read the 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.
- Conditions
- Simple Hand Lacerations
- Being tested
- cephalexin, clindamycin, placebo
- Keywords
- wounds and lacerations, hand, infection, Antibiotics, antibacterial agents
- Medical subject headings
- Wounds and Injuries, Lacerations, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalexinDrug
500 mg (two 250 mg capsules) every 6 hours for 7 days
clindamycinDrug
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
placeboDrug
Two placebo capsules every 6 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| clindamycin | Active comparator | clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days Receives: Drug: clindamycin |
| cepahlexin | Active comparator | Not described Receives: Drug: cephalexin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Simple Hand LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital, Kings County Hospital Center
- Responsible party
- Principal investigator, Shahriar Zehtabchi, State University of New York - Downstate Medical Center
- Investigators
- shahriar zehtabchi, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155154
- Sponsor's protocol ID
- 09-130
- Status last verified
- Nov 2014
- First submitted
- 29 Jun 2010
- Last updated
- 7 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
- ClinicalTrials.gov ID
- NCT01155154
- Acronym / sponsor ID
- 09-130
- Conditions
- Simple Hand Lacerations
- Keywords
- wounds and lacerations, hand, infection, Antibiotics, antibacterial agents
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 73 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- Staten Island University Hospital, Kings County Hospital Center
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 4 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clindamycin | Active comparator | Drug: clindamycinclindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days |
| cepahlexin | Active comparator | Drug: cephalexin |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cephalexin500 mg (two 250 mg capsules) every 6 hours for 7 days | Drug | cepahlexin |
| clindamycin300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days | Drug | clindamycin |
| placeboTwo placebo capsules every 6 hours for 7 days | Drug | Placebo |
Primary outcome
Number of Participants With Presence of Wound Infection
Time frame: 2 weeks
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shahriar zehtabchi, MD principal investigator
State University of New York - Downstate Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cephalexin and clindamycin in people with Simple Hand Lacerations, run by State University of New York - Downstate Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Presence of Wound Infection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.