Bone DiseaseskitNCT03050203
Custom Pack in Spine Surgery
A study testing custom pack in people with Bone Diseases and Spine Cancer, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Diseases, Spine Cancer, Spine Osteoarthritis
- What is being tested?
- custom pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2015to 30 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative spinal disease from 2 to 4 levels,
- Oncologic spine disease with only decompression and stabilization.
Who cannot join
- Revision surgeries,
- Minimally invasive interventions,
- Interventions that provide a dual access, and
- Patients who refuse consent to experimentation.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Bone Diseases, Spine Cancer, Spine Osteoarthritis
- Being tested
- custom pack, standard care
- Medical subject headings
- Bone Diseases, Spinal Cord Neoplasms, Osteoarthritis, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom packOther
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 careOther
The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
| Study group | Role | What they receive |
|---|---|---|
| custom pack | Experimental | Not described Receives: Other: custom pack |
| standard care | Active comparator | Not described Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Dissecting Time
minutes from the start of the dissection to complete bone cleaning
Measured: up to the first day post intervention
Secondary outcomes (6)
Surgery Time
from the incision to the patient's sutures (minutes)
Measured: up to the first day post intervention
Postoperative Complications
number of early wound infection
Measured: up to 2 weeks
Numbers of Materials Wasted
amount of open sterile materials not used
Measured: 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.
Measured: 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.
Measured: up to the first 3 days post intervention
Length of Stay
number of days spent in hospital
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start2 Sep 2015
- Primary completion16 Jun 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annamaria Nicolini, RN, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050203
- Sponsor's protocol ID
- 0033168
- Acronym
- kit
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03050203
- Acronym / sponsor ID
- kit / 0033168
- Conditions
- Bone Diseases, Spine Cancer, Spine Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 16 Jun 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| custom pack | Experimental | Other: custom pack |
| standard care | Active comparator | Other: standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Degenerative spinal disease from 2 to 4 levels,
- Oncologic spine disease with only decompression and stabilization.
Key exclusion criteria (4 listed)
- Revision surgeries,
- Minimally invasive interventions,
- Interventions that provide a dual access, and
- Patients who refuse consent to experimentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom packPreparation 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. | Other | custom pack |
| standard careThe scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery | Other | standard care |
Primary outcome
Soft Tissue Dissecting Time
Time frame: up to the first day post intervention
minutes from the start of the dissection to complete bone cleaning
6 secondary outcomes
Surgery Time
Time frame: up to the first day post intervention
Postoperative Complications
Time frame: up to 2 weeks
Numbers of Materials Wasted
Time frame: up to the first day post intervention
Blood Loss
Time frame: up to 2 weeks
Pain (Score on the "Numeric Rating Scale")
Time frame: up to the first 3 days post intervention
Length of Stay
Time frame: up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annamaria Nicolini, RN principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom pack in people with Bone Diseases and Spine Cancer, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Dissecting Time (time frame: up to the first day post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.