Clinical Trials Directory

Trials / Completed

CompletedNCT04492826

Postoperative Surgical Site Infection afterENT Bone Flap Surgery

Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019

Status
Completed
Phase
Study type
Observational
Enrollment
39 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPostoperative infections rateAssess the postoperative infection rate after otolaryngology bone flap surgery.

Timeline

Start date
2012-09-01
Primary completion
2012-09-01
Completion
2019-02-01
First posted
2020-07-30
Last updated
2020-07-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04492826. Inclusion in this directory is not an endorsement.