Postoperative Surgical Site Infection afterENT Bone Flap Surgery

Otolaryngology Clinical Trial

— SSI-flap  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492826
• Other study ID #: 20_5052
• Status: Completed
• Start date: September 2012
• Est. completion date: February 2019

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2019
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Flap Surgery
• Communicable Diseases
• Infection
• Operating Site
• Otolaryngology
• Post-operative Surgery
• Rate of Infections
• Surgical Wound Infection

Intervention

Procedure:
• Postoperative infections rate
Assess the postoperative infection rate after otolaryngology bone flap surgery.

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infections rate after otolaryngology bone flap surgery	Assess the postoperative infection rate after bone flap otolaryngology surgery	1 year