Custom Pack in Spine Surgery

Study Overview
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Brief Summary
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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 .

Official Title
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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

Conditions
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Bone Diseases, Spine Cancer, Spine Osteoarthritis

Intervention / Treatment
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* Other: custom pack
* Other: standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: custom pack<br> | Other: custom pack<br>* 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.<br>|
| Active Comparator: standard care<br> | Other: standard care<br>* The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery<br>|

What is the study measuring?
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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 |