Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Cefazolin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound Infection focused on measuring head and neck surgery, surgical wound infection, antibiotic prophylaxis
Eligibility 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).
Sites / Locations
- Department of Otolaryngology, Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cefazolin
Placebo
Arm Description
Cefazolin 1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision.
1 dose of placebo - NaCl 0.9% with no drugs added to it.
Outcomes
Primary Outcome Measures
Surgical wound infection, sepsis, bacteremia.
Secondary Outcome Measures
Length of stay
Length of post-operative stay
Drug-induced adverse reactions
Full Information
NCT ID
NCT01980082
First Posted
November 4, 2013
Last Updated
February 6, 2018
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01980082
Brief Title
Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Official Title
Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 7, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
head and neck surgery, surgical wound infection, antibiotic prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cefazolin
Arm Type
Active Comparator
Arm Description
Cefazolin
1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 dose of placebo - NaCl 0.9% with no drugs added to it.
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Other Intervention Name(s)
Cefamezine
Intervention Description
Antibiotic
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Surgical wound infection, sepsis, bacteremia.
Time Frame
1 month from surgery
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of post-operative stay
Time Frame
1 month from surgery
Title
Drug-induced adverse reactions
Time Frame
1 month from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yotam Shkedy, MD
Organizational Affiliation
Rabin Medical Center, Petach Tikva, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Rabin Medical Center
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16552259
Citation
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.
Results Reference
background
PubMed Identifier
1825518
Citation
Velanovich V. A meta-analysis of prophylactic antibiotics in head and neck surgery. Plast Reconstr Surg. 1991 Mar;87(3):429-34; discussion 435.
Results Reference
background
PubMed Identifier
15068519
Citation
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.
Results Reference
background
PubMed Identifier
3573905
Citation
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.
Results Reference
background
PubMed Identifier
3968563
Citation
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.
Results Reference
background
PubMed Identifier
30027615
Citation
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.
Results Reference
derived
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Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
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