NCT00467948

Brief Summary

Patients who need major head \& neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
Last Updated

May 1, 2007

Status Verified

June 1, 2003

First QC Date

April 29, 2007

Last Update Submit

April 30, 2007

Conditions

Laryngeal Cancer

Keywords

clean contaminated, laryngectomy, wound infection

Outcome Measures

Primary Outcomes (1)

  • wound infection

    prospective

Secondary Outcomes (1)

  • drug complication

    3 week after surgery

Interventions

cefazolinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study.

You may not qualify if:

  • Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam khomaini hospital

Tehran, Tehran Province, 19799, Iran

Location

MeSH Terms

Conditions

Laryngeal NeoplasmsWound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesInfections

Intervention Hierarchy (Ancestors)

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

Study Officials

  • taghi khorsandi, professor

    tehran university of medical science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2007

First Posted

May 1, 2007

Study Start

June 1, 2004

Study Completion

March 1, 2006

Last Updated

May 1, 2007

Record last verified: 2003-06

Locations

IR(1)