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
| Registry | NCT03050203, acronym kit |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 37 (Actual) |
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| Sponsor | Istituto Ortopedico Rizzoli (Other) |
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| Conditions | Bone Diseases, Spine Cancer, Spine Osteoarthritis |
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| Interventions | custom pack, standard care (Other) |
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| Dates | start 2015-09-02, primary completion 2016-06-16, completion 2016-07-30, first posted 2017-02-10, last updated 2019-01-28 |
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| Locations | 1 site in Italy |
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Related Papers Related Patents Related Grants Related Experts
All trials for Bone Diseases All trials for Spine Cancer All trials of custom pack All trials of standard care
-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 .
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| custom pack | Experimental | Other: custom pack | |
| standard care | Active comparator | Other: standard care | |
- custom pack (Other): 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.
- standard care (Other): The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
+Outcome measures
Primary outcomes
- Soft Tissue Dissecting Time [up to the first day post intervention]: minutes from the start of the dissection to complete bone cleaning
Secondary outcomes
- Surgery Time [up to the first day post intervention]: from the incision to the patient's sutures (minutes)
- Postoperative Complications [up to 2 weeks]: number of early wound infection
- Numbers of Materials Wasted [up to the first day post intervention]: amount of open sterile materials not used
- Blood Loss [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") [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 [up to 2 weeks]: number of days spent in hospital
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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.
+Posted results
Participant flow
| Milestone | Custom Pack | Standard Care |
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| Started | 19 | 18 |
| Completed | 19 | 18 |
| Not completed | 0 | 0 |
Outcome results
- Soft Tissue Dissecting Time (Primary), Mean, minues: Custom Pack 38.6 +/- 11.1; Standard Care 34 +/- 19.5
- Surgery Time (Secondary)
- Postoperative Complications (Secondary)
- Numbers of Materials Wasted (Secondary)
- Blood Loss (Secondary)
- Pain (Score on the "Numeric Rating Scale") (Secondary)
- Length of Stay (Secondary)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Custom Pack | 0 | 0/19 (0.0%) | 0/19 (0.0%) |
| Standard Care | 0 | 0/18 (0.0%) | 0/18 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| Istituto Ortopedico Rizzoli | Bologna | Italy | |
+Investigators