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Custom Pack in Spine Surgery (kit)

Primary Purpose

Bone Diseases, Spine Cancer, Spine Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
custom pack
standard care
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

custom pack

standard care

Arm Description

Outcomes

Primary Outcome Measures

Soft Tissue Dissecting Time
minutes from the start of the dissection to complete bone cleaning

Secondary Outcome Measures

Surgery Time
from the incision to the patient's sutures (minutes)
Postoperative Complications
number of early wound infection
Numbers of Materials Wasted
amount of open sterile materials not used
Blood Loss
Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.
Pain (Score on the "Numeric Rating Scale")
Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.
Length of Stay
number of days spent in hospital

Full Information

First Posted
February 1, 2017
Last Updated
August 8, 2018
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03050203
Brief Title
Custom Pack in Spine Surgery
Acronym
kit
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2, 2015 (Actual)
Primary Completion Date
June 16, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases, Spine Cancer, Spine Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
custom pack
Arm Type
Experimental
Arm Title
standard care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
custom pack
Intervention Description
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
Intervention Name(s)
standard care
Intervention Description
The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
Primary Outcome Measure Information:
Title
Soft Tissue Dissecting Time
Description
minutes from the start of the dissection to complete bone cleaning
Time Frame
up to the first day post intervention
Secondary Outcome Measure Information:
Title
Surgery Time
Description
from the incision to the patient's sutures (minutes)
Time Frame
up to the first day post intervention
Title
Postoperative Complications
Description
number of early wound infection
Time Frame
up to 2 weeks
Title
Numbers of Materials Wasted
Description
amount of open sterile materials not used
Time Frame
up to the first day post intervention
Title
Blood Loss
Description
Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.
Time Frame
up to 2 weeks
Title
Pain (Score on the "Numeric Rating Scale")
Description
Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.
Time Frame
up to the first 3 days post intervention
Title
Length of Stay
Description
number of days spent in hospital
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Nicolini, RN
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Custom Pack in Spine Surgery

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