Antibiotics in Free Flaps Reconstructions

May 5, 2015 updated by: thomas.muecke, Technical University of Munich

The Value of Perioperative Antibiotics on the Success of Oral Free Flap Reconstructions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design and Patient Recruitment All clinical investigations have been conducted according to the principles expressed in the Declaration of Helsinki. Patient consent was written. Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All patients were prospectively evaluated.

Postoperative Care The investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. The specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days.

Data Analysis Recorded parameters included: age, sex, preoperative medical history, American society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the wounds.

Descriptive statistics for quantitative variables are given as the mean ± standard deviation. The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM® SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0, 2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences were considered to be statistically significant for a two-sided p-value of less than 0.05.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
no antibiotics
Active Comparator: experimental group
drug administration (antibiotic)
Drug: antibiotic (use of penicilline, unacid, cefuroxime)
prophylactic antibiotics
Other Names:
  • use of penicilline, unacid, cefuroxime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)
Time Frame: participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks
participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Chair: Denys J Loeffelbein, MD, DDS, PhD, Department of oral and maxillofacial surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKG-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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