Postoperative Surgical Site Infection afterENT Bone Flap Surgery

NCT ID: NCT04492826

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2019-02-28

Brief Summary

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In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.

However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).

The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.

We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.

Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.

The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.

Detailed Description

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Conditions

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Rate of Infections Operating Site Post-operative Surgery Bone Flap Surgery Otolaryngology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infected patients

patients with bone flap surgeries

Postoperative infections rate

Intervention Type PROCEDURE

Assess the postoperative infection rate after otolaryngology bone flap surgery.

Interventions

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Postoperative infections rate

Assess the postoperative infection rate after otolaryngology bone flap surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology department, since september 2012 and until January 2019

Exclusion Criteria

* patient's opposition to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de la Croix-Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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20_5052

Identifier Type: -

Identifier Source: org_study_id

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