Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Wound Infection
Intervention: Cefazolin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Rabin Medical Center Official(s) and/or principal investigator(s): Yotam Shkedy, MD, Principal Investigator, Affiliation: Rabin Medical Center, Petach Tikva, Israel
Overall contact: Yotam Shkedy, MD, Phone: +972-3-9376458, Email: yotamyo@clalit.org.il
Summary
We hypothesized that revision clean head & neck surgery may have a higher rate of wound
infection that may be lowered with prophylactic antibiotic treatment.
Clinical Details
Official title: Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Surgical wound infection, sepsis, bacteremia.
Secondary outcome: Length of stayDrug-induced adverse reactions
Detailed description:
Surgical wound infection (SWI) is a common complication in many operations, including head
and neck (H&N) surgery, with reported rates ranging between 3. 5 to 87%. While prophylactic
antibiotic use has been shown to decrease SWI in clean-contaminated and contaminated
surgery, its use in clean surgery is debatable. In most types of clean surgery the value of
prophylactic antibiotics is minimal, however in some cases it might be justified, including
in radical neck dissections, in a previously irradiated neck, those with a tracheostomy and
immunosuppressed patients - although there is no consensus regarding these risk factors.
Previous research has shown that adherence to guidelines regarding prophylactic antibiotic
use is lacking, with one study showing a greater than 40% rate of inappropriate antibiotic
administration. This may be partially attributed to some patients having other risk factors,
not covered by existing guidelines.
One such risk factor is previous H&N surgery. While there are no studies addressing this
issue in H&N surgeries, a study in clean neurosurgical operations has shown an almost
trice-fold increase in SWI rates in some operations (4% vs. 13%).
The purpose of this study is to investigate the effect of prophylactic antibiotic use in
repeat clean H&N surgery.
This is a double-blind, randomized, placebo-controlled study. The study will be conducted at
the Otolaryngology department in Rabin Medical Center, Petah Tikva.
Patients will be randomly assigned to 2 groups, with each group composed of 50 patients: a
study group which will receive 1 dose of intravenous Cefazolin 1 gram/2 gram if body mass
index > 40 or a control group which will receive 1 dose of placebo. The drug/placebo will be
given 30-60 minutes prior to incision. Previous studies have shown no benefit for longer
duration of prophylactic antibiotic coverage. Both the study drug and placebo will be
prepared by a designated nurse from the department. The nurse will use a randomization site
(www. random. org with min set to 1 and max set to 1000) to give each participant a number. A
predefined Excel table will contain an assignment of each number to one of the groups. Only
this nurse will know the assignment of each patient and she will not be assessing the
patient post-operatively. The patients, surgeons and researchers will be blinded to the
patients' assignments.
The status of the surgical wound will be assessed daily during hospitalization and again on
the planned follow-up visit 3-4 weeks after discharge. During the follow-up visit, patients
will be questions regarding symptoms and signs of SWI and antibiotic prescriptions given
during the post-operative period.
SWI diagnosis will be according to the Center for Disease Control's "guideline for surgical
site infection". Treatment of SWI will be according to regular department protocols (with no
regard to study allocation).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Previous H&N surgery.
- Planned second H&N clean surgery (the definition of a second H&N surgery is a surgery
which will include the same skin incision as the previous operation).
Exclusion Criteria:
- Previous neck irradiation.
- Tracheostomy status.
- Immunosuppression.
- Concurrent infection which requires antibiotic use.
- Any other factor during the surgery which the surgeon estimates requires prophylactic
antibiotic use.
- Allergy to cephalosporins and allergy to penicillin which precludes the use of
cephalosporins (e. g. anaphylaxis).
Locations and Contacts
Yotam Shkedy, MD, Phone: +972-3-9376458, Email: yotamyo@clalit.org.il
Department of Otolaryngology, Rabin Medical Center, Petach Tikva, Israel; Recruiting Yotam Shkedy, MD, Phone: +972-3-9376458, Email: yotamyo@clalit.org.il Yotam Shkedy, MD, Principal Investigator Thomas Spitzer, MD, Sub-Investigator Yuval Nachalon, MD, Sub-Investigator
Additional Information
Related publications: Simo R, French G. The use of prophylactic antibiotics in head and neck oncological surgery. Curr Opin Otolaryngol Head Neck Surg. 2006 Apr;14(2):55-61. Review. Velanovich V. A meta-analysis of prophylactic antibiotics in head and neck surgery. Plast Reconstr Surg. 1991 Mar;87(3):429-34; discussion 435. Seven H, Sayin I, Turgut S. Antibiotic prophylaxis in clean neck dissections. J Laryngol Otol. 2004 Mar;118(3):213-6. Brown BM, Johnson JT, Wagner RL. Etiologic factors in head and neck wound infections. Laryngoscope. 1987 May;97(5):587-90. Tenney JH, Vlahov D, Salcman M, Ducker TB. Wide variation in risk of wound infection following clean neurosurgery. Implications for perioperative antibiotic prophylaxis. J Neurosurg. 1985 Feb;62(2):243-7.
Starting date: January 2014
Last updated: November 11, 2014
|