Postoperative Surgical Site Infection afterENT Bone Flap Surgery

NCT04492826 | Completed

• 1 other identifier: 20_5052
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

bone flap surgery; postoperative surgical infection

Outcome Measures

Primary Outcomes (1)

• Postoperative infections rate after otolaryngology bone flap surgery

  Assess the postoperative infection rate after bone flap otolaryngology surgery

  1 year

Study Arms (1)

Infected patients

patients with bone flap surgeries

Procedure: Postoperative infections rate

Interventions

Postoperative infections rate PROCEDURE

Assess the postoperative infection rate after otolaryngology bone flap surgery.

Infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient operated on for bone flap surgery by the Otorhinolaryngology surgery team in Croix-Rousse hospital (Pr CERUSE)

You may qualify if:

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

You may not qualify if:

• patient's opposition to participate in the study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

FR (1)