Antibiotic Prophylaxis for Simple Hand Lacerations

• Sponsor: State University of New York - Downstate Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01155154
• Collaborator: Staten Island University Hospital (Other), Kings County Hospital Center (Other)
• Enrollment: 73
• Locations: 3
• Arms: 3
• Duration (Months): 24
• Patients Per Site: 24.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?

Condition or Disease	Intervention/Treatment	Phase
Simple Hand Lacerations	Drug: cephalexin; Drug: clindamycin; Drug: placebo	N/A

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

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: clindamycin clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days	Drug: clindamycin; 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
Active Comparator: cepahlexin	Drug: cephalexin; 500 mg (two 250 mg capsules) every 6 hours for 7 days
Placebo Comparator: Placebo	Drug: placebo; Two placebo capsules every 6 hours for 7 days

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kings County Hospital Center	Brooklyn	New York	United States	11203
2	State University of New York, Downstate Medical Center	Brooklyn	New York	United States	11203
3	Staten Island University Hospital	Staten Island	New York	United States	10305

Sponsors and Collaborators

• State University of New York - Downstate Medical Center
• Staten Island University Hospital
• Kings County Hospital Center

Investigators

• Principal Investigator: shahriar zehtabchi, MD, State University of New York - Downstate Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shahriar Zehtabchi, Professor of Emergency Medicine, State University of New York - Downstate Medical Center
• ClinicalTrials.gov Identifier: NCT01155154
• Other Study ID Numbers: 09-130
• First Posted: Jul 1, 2010
• Last Update Posted: Nov 7, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Shahriar Zehtabchi, Professor of Emergency Medicine, State University of New York - Downstate Medical Center: wounds and lacerations; hand; infection; Antibiotics; antibacterial agents
• Additional relevant MeSH terms: Lacerations; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin

Study Results

Participant Flow

Arm/Group Title	Clindamycin	Cepahlexin	Placebo
Arm/Group Description	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	cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days	placebo: Two placebo capsules every 6 hours for 7 days
Period Title: Overall Study
STARTED	25	24	24
COMPLETED	25	24	24
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Clindamycin	Cepahlexin	Placebo	Total
Arm/Group Description	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	cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days	placebo: Two placebo capsules every 6 hours for 7 days	Total of all reporting groups
Overall Participants	25	24	24	73
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	39	42	40	41
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	23 92%	20 83.3%	20 83.3%	63 86.3%
>=65 years	2 8%	4 16.7%	4 16.7%	10 13.7%
Sex: Female, Male (Count of Participants)
Female	10 40%	6 25%	5 20.8%	21 28.8%
Male	15 60%	18 75%	19 79.2%	52 71.2%
Region of Enrollment (participants) [Number]
United States	25 100%	24 100%	24 100%	73 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Presence of Wound Infection
Description	Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clindamycin	Cepahlexin	Placebo
Arm/Group Description	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	cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days	placebo: Two placebo capsules every 6 hours for 7 days
Measure Participants	25	24	24
Number [participants]	0 0%	0 0%	1 4.2%

Adverse Events

Arm/Group Title	Clindamycin		Cepahlexin		Placebo
Arm/Group Description	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		cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days		placebo: Two placebo capsules every 6 hours for 7 days
All Cause Mortality
	Clindamycin		Cepahlexin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Clindamycin		Cepahlexin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Clindamycin		Cepahlexin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/25 (12%)		1/24 (4.2%)		1/24 (4.2%)
Cardiac disorders
palpitation	1/25 (4%)	1	0/24 (0%)	0	0/24 (0%)	0
Gastrointestinal disorders
diarrhea	1/25 (4%)	1	0/24 (0%)	0	1/24 (4.2%)	1
Metal After-taste in th mouth	1/25 (4%)	1	0/24 (0%)	0	0/24 (0%)	0
Nervous system disorders
dizziness	0/25 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.