Custom Pack in Spine Surgery (kit)

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

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 Overview

• Status: Completed
• Conditions: Bone Diseases; Spine Osteoarthritis; Spine Cancer
• Intervention / Treatment: Other: custom pack; Other: standard care

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: custom pack	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.
ACTIVE_COMPARATOR: standard care	Other: standard care; The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft Tissue Dissecting Time	minutes from the start of the dissection to complete bone cleaning	up to the first day post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	from the incision to the patient's sutures (minutes)	up to the first day post intervention
Postoperative Complications	number of early wound infection	up to 2 weeks
Numbers of Materials Wasted	amount of open sterile materials not used	up to the first day post intervention
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.	up to 2 weeks
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.	up to the first 3 days post intervention
Length of Stay	number of days spent in hospital	up to 2 weeks

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Annamaria Nicolini, RN, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2015
• Primary Completion (ACTUAL): June 16, 2016
• Study Completion (ACTUAL): July 30, 2016

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Osteoarthritis; Bone Diseases, Infectious; Bone Diseases; Spondylitis; Spondylarthritis; Osteoarthritis, Spine
• Other Study ID Numbers: 0033168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No