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Cephalexin for Surgical Site Infection

Phase 4
Recruiting
Led By Mariana Phillips, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Eligible Conditions
  • Surgical Site Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Development of surgical site infection within 30 days of surgery

Side effects data

From 2013 Phase 2 & 3 trial • 2265 Patients • NCT00729937
21%
Nausea
16%
Headache
15%
Diarrhoea
14%
Abscess
10%
Vomiting
7%
Dizziness
6%
Abdominal pain upper
4%
Constipation
3%
Pyrexia
3%
Rash
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abscess, Placebo
Abscess, TMP/SMX
Infected Wound, TMP/SMX
Infected Wound, Clindamycin
Cellulitis, Cephalexin and TMP/SMX
Cellulitis, Cephalexin

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Antibiotic- noseExperimental Treatment1 Intervention
The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the nose. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.
Group II: Antibiotic- legExperimental Treatment1 Intervention
The administration time of the oral antibiotics will be 30 minutes prior to incision in the leg group. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered
Group III: Antibiotic- earExperimental Treatment1 Intervention
The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the ear. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.
Group IV: Placebo - legPlacebo Group1 Intervention
If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.
Group V: Placebo- nosePlacebo Group1 Intervention
If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.
Group VI: Placebo- earPlacebo Group1 Intervention
If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clindamycin
FDA approved

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
70 Previous Clinical Trials
11,115 Total Patients Enrolled
Mariana Phillips, MD4.220 ReviewsPrincipal Investigator - Carilion Clinic Dermatology and Mohs Surgery
Carilion Clinic
1 Previous Clinical Trials
30 Total Patients Enrolled
5Patient Review
Dr.Phillips was excellent. They were obviously skilled and competent, explained my problem well, and removed two biopsies without leaving a scar. I would definitely go to them again.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery
Mariana Phillips 2020. "Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04580472.
~356 spots leftby Apr 2025
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