NCT02436083

Brief Summary

The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4

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

July 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

4.9 years

First QC Date

March 9, 2015

Last Update Submit

May 5, 2015

Conditions

Postoperative Infection

Outcome Measures

Primary Outcomes (1)

  • Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)

    participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks

Study Arms (2)

control

NO INTERVENTION

no antibiotics

experimental group

ACTIVE COMPARATOR

drug administration (antibiotic)

Drug: antibiotic (use of penicilline, unacid, cefuroxime)

Interventions

antibiotic (use of penicilline, unacid, cefuroxime)DRUG

prophylactic antibiotics

Also known as: use of penicilline, unacid, cefuroxime
experimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps.

You may not qualify if:

  • Healthy humans.
  • Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mucke T, Rohleder NH, Rau A, Ritschl LM, Kesting M, Wolff KD, Mitchell DA, Loeffelbein DJ. The value of perioperative antibiotics on the success of oral free flap reconstructions. Microsurgery. 2015 Oct;35(7):507-11. doi: 10.1002/micr.22470. Epub 2015 Aug 7.

    PMID: 26251066DERIVED

MeSH Terms

Interventions

Anti-Bacterial AgentsCefuroxime

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Denys J Loeffelbein, MD, DDS, PhD

    Department of Oral and Maxillofacial Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
responsible consultant

Study Record Dates

First Submitted

March 9, 2015

First Posted

May 6, 2015

Study Start

July 1, 2007

Primary Completion

June 1, 2012

Study Completion

December 1, 2014

Last Updated

May 6, 2015

Record last verified: 2015-05