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The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions

NCT03357419 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-04

No results posted yet for this study

Summary

The incidence of surgical site infection (SSI) infection in clean dermatologic surgery is very low, between 1-3%. Studies have demonstrated a much higher infection rate in skin excision surgeries in the lower limbs, up to 10% in most studies, and even 35.7% infection rate in a recent study from Australia.

To our knowledge, there are no clinical trials demonstrating the efficacy of prophylactic antibiotic given prior to skin lesion excision from the lower limbs.

Conditions

  • Skin Lesion

Interventions

DRUG

Cephalexin

The subjects will be randomized, at the operation day, to one of two treatment groups: * group 1: prophylactic antibiotic * group 2: placebo oral capsule * Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization. * Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses.

DRUG

Placebo oral capsule

The subjects will be randomized, at the operation day, to one of two treatment groups: * group 1: prophylactic antibiotic * group 2: placebo * Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization. * Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yehuda Ullmann, Proffesor · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-11-30
Completion
2022-03-27

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357419 on ClinicalTrials.gov