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Custom Pack in Spine Surgery (kit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03050203
Recruitment Status : Completed
First Posted : February 10, 2017
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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 .

Condition or disease Intervention/treatment Phase
Bone Diseases Spine Cancer Spine Osteoarthritis Other: custom pack Other: standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2, 2015
Actual Primary Completion Date : June 16, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Soft Tissue Dissecting Time [ Time Frame: up to the first day post intervention ]
    minutes from the start of the dissection to complete bone cleaning

Secondary Outcome Measures :
  1. Surgery Time [ Time Frame: up to the first day post intervention ]
    from the incision to the patient's sutures (minutes)

  2. Postoperative Complications [ Time Frame: up to 2 weeks ]
    number of early wound infection

  3. Numbers of Materials Wasted [ Time Frame: up to the first day post intervention ]
    amount of open sterile materials not used

  4. Blood Loss [ Time Frame: up to 2 weeks ]
    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.

  5. Pain (Score on the "Numeric Rating Scale") [ Time Frame: up to the first 3 days post intervention ]
    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.

  6. Length of Stay [ Time Frame: up to 2 weeks ]
    number of days spent in hospital

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03050203

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Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
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Principal Investigator: Annamaria Nicolini, RN Istituto Ortopedico Rizzoli
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Responsible Party: Istituto Ortopedico Rizzoli Identifier: NCT03050203    
Other Study ID Numbers: 0033168
First Posted: February 10, 2017    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases
Osteoarthritis, Spine
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases