Custom Pack in Spine Surgery (kit)
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ClinicalTrials.gov Identifier: NCT03050203 |
Recruitment Status :
Completed
First Posted : February 10, 2017
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bone Diseases Spine Cancer Spine Osteoarthritis | Other: custom pack Other: standard care | Not Applicable |
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 |

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 |
- Soft Tissue Dissecting Time [ Time Frame: up to the first day post intervention ]minutes from the start of the dissection to complete bone cleaning
- Surgery Time [ Time Frame: up to the first day post intervention ]from the incision to the patient's sutures (minutes)
- Postoperative Complications [ Time Frame: up to 2 weeks ]number of early wound infection
- Numbers of Materials Wasted [ Time Frame: up to the first day post intervention ]amount of open sterile materials not used
- 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.
- 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.
- Length of Stay [ Time Frame: up to 2 weeks ]number of days spent in hospital

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT03050203
Italy | |
Istituto Ortopedico Rizzoli | |
Bologna, Italy, 40136 |
Principal Investigator: | Annamaria Nicolini, RN | Istituto Ortopedico Rizzoli |
Responsible Party: | Istituto Ortopedico Rizzoli |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bone Diseases Osteoarthritis, Spine Spondylarthritis Osteoarthritis Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Spondylitis Spinal Diseases |