CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
custom pack +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03050203
NCT03050203N/ACompleted

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

Istituto Ortopedico Rizzoli·interventional·Posted Feb 10, 2017·Updated Jan 28, 2019

In Brief

A clinical study evaluating custom pack and standard care for Bone Diseases and 2 related conditions. Completed, enrolled 37 participants across 1 site.

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 10, 2017
Enrollment StartSep 2, 2015
Primary CompletionJun 16, 2016
Study CompletionJul 30, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago

Interventions

custom packother

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.

standard careother

The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery