Antibiotics in Free Flaps Reconstructions

Postoperative Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436083
• Other study ID #: MKG-2007
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2015
• Last updated: May 5, 2015
• Start date: July 2007
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Infection

Intervention

Drug:
• antibiotic (use of penicilline, unacid, cefuroxime)
prophylactic antibiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes