NCT01980082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

November 4, 2013

Last Update Submit

February 6, 2018

Conditions

Surgical Wound Infection

Keywords

head and neck surgerysurgical wound infectionantibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Surgical wound infection, sepsis, bacteremia.

    1 month from surgery

Secondary Outcomes (2)

  • Length of stay

    1 month from surgery

  • Drug-induced adverse reactions

    1 month from surgery

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

Cefazolin 1 gram/2 gram if body mass index \> 40 - one time dose, 30-60 min prior to incision.

Drug: Cefazolin

Placebo

PLACEBO COMPARATOR

1 dose of placebo - NaCl 0.9% with no drugs added to it.

Drug: Placebo

Interventions

CefazolinDRUG

Antibiotic

Also known as: Cefamezine
Cefazolin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (6)

  • 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.

    PMID: 16552259BACKGROUND

  • Velanovich V. A meta-analysis of prophylactic antibiotics in head and neck surgery. Plast Reconstr Surg. 1991 Mar;87(3):429-34; discussion 435.

    PMID: 1825518BACKGROUND

  • 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.

    PMID: 15068519BACKGROUND

  • 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.

    PMID: 3573905BACKGROUND

  • 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.

    PMID: 3968563BACKGROUND

  • 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.

    PMID: 30027615DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yotam Shkedy, MD

    Rabin Medical Center, Petach Tikva, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

January 1, 2014

Primary Completion

June 7, 2017

Study Completion

July 7, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

IL(1)