Clinical trial · Interventional
Custom Pack in Spine Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Diseases | — | UNRESOLVED | — |
| Spine Cancer | Malignant Spinal Cord Neoplasm | ALIAS | 0.90 |
| Spine Osteoarthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| custom pack | Other | — | UNRESOLVED |
| standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- custom pack
- interventionNames
- Other: custom pack
- type
- ACTIVE_COMPARATOR
- label
- standard care
- interventionNames
- Other: standard care
Primary outcomes (1)
- measure
- Soft Tissue Dissecting Time
- timeFrame
- up to the first day post intervention
- description
- minutes from the start of the dissection to complete bone cleaning
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available