Custom Pack in Spine Surgery

NCT ID: NCT03050203

Last Updated: 2019-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-02

Study Completion Date

2016-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Diseases Spine Cancer Spine Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

custom pack

Group Type EXPERIMENTAL

custom pack

Intervention Type OTHER

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 care

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

standard care

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Degenerative spinal disease from 2 to 4 levels,
* Oncologic spine disease with only decompression and stabilization.

Exclusion Criteria

* Revision surgeries,
* Minimally invasive interventions,
* Interventions that provide a dual access, and
* Patients who refuse consent to experimentation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annamaria Nicolini, RN

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0033168

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.