Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery

We hypothesized that revision clean head & neck surgery may have a higher rate of wound infection that may be lowered with prophylactic antibiotic treatment.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Drug: Placebo; Drug: Cefazolin

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).

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Department of Otolaryngology, Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cefazolin; Cefazolin 1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision.	Drug: Cefazolin; Antibiotic; Other Names: Cefamezine
Placebo Comparator: Placebo; 1 dose of placebo - NaCl 0.9% with no drugs added to it.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical wound infection, sepsis, bacteremia.	1 month from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of post-operative stay	1 month from surgery
Drug-induced adverse reactions		1 month from surgery

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Yotam Shkedy, MD, Rabin Medical Center, Petach Tikva, Israel

Publications and helpful links

General 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. doi: 10.1097/01.moo.0000193183.30687.d5.
• 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. doi: 10.1258/002221504322927991.
• Brown BM, Johnson JT, Wagner RL. Etiologic factors in head and neck wound infections. Laryngoscope. 1987 May;97(5):587-90. doi: 10.1288/00005537-198705000-00009.
• 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. doi: 10.3171/jns.1985.62.2.0243.
• Shkedy Y, Stern S, Nachalon Y, Levi D, Menasherov I, Reifen E, Shpitzer T. Antibiotic prophylaxis in clean head and neck surgery: A prospective randomised controlled trial. Clin Otolaryngol. 2018 Dec;43(6):1508-1512. doi: 10.1111/coa.13195. Epub 2018 Aug 14.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: antibiotic prophylaxis; head and neck surgery; surgical wound infection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: ProphylacticABxHN