NCT03050203

Custom Pack in Spine Surgery

Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .

Conditions

• Bone Diseases
• Spine Cancer
• Spine Osteoarthritis

Interventions

Type	Name	Description
OTHER	custom pack	Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
OTHER	standard care	The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

Timeline

• Start date: 2015-09-02
• Primary completion: 2016-06-16
• Completion: 2016-07-30
• First posted: 2017-02-10
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

1 site across 1 country: Italy