Custom Pack in Spine Surgery

NCT03050203 | Completed Results

• 1 other identifier: 0033168
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Soft Tissue Dissecting Time

  minutes from the start of the dissection to complete bone cleaning

  up to the first day post intervention

Secondary Outcomes (6)

• Surgery Time

  up to the first day post intervention

• Postoperative Complications

  up to 2 weeks

• Numbers of Materials Wasted

  up to the first day post intervention

• Blood Loss

  up to 2 weeks

• Pain (Score on the "Numeric Rating Scale")

  up to the first 3 days post intervention

Study Arms (2)

custom pack

EXPERIMENTAL

Other: custom pack

standard care

ACTIVE COMPARATOR

Other: standard care

Interventions

custom pack 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.

custom pack

standard care OTHER

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

standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Bone Diseases; Spinal Cord Neoplasms; Osteoarthritis, Spine

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Cristiana Forni
• Organization: Istituto Ortopedico Rizzoli

cristiana.forni@ior.it

0039516366

Study Officials

• Annamaria Nicolini, RN

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 10, 2017
• Study Start: September 2, 2015
• Primary Completion: June 16, 2016
• Study Completion: July 30, 2016
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)