Bone Diseases, Spine Cancer, Spine Osteoarthritis
Conditions
Brief 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 .
Interventions
OTHERcustom 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.
OTHERstandard care
The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue Dissecting Time | up to the first day post intervention | minutes from the start of the dissection to complete bone cleaning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Surgery Time | up to the first day post intervention | from the incision to the patient's sutures (minutes) |
| 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 |
| 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Custom Pack 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. | 19 |
| Standard Care standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Custom Pack | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 16.7 | 54.8 years STANDARD_DEVIATION 12.4 | 53 years STANDARD_DEVIATION 14.7 |
| degenerative disease | 5 Participants | 5 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Soft Tissue Dissecting Time
minutes from the start of the dissection to complete bone cleaning
Time frame: up to the first day post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom Pack | Soft Tissue Dissecting Time | 38.6 minues | Standard Deviation 11.1 |
| Standard Care | Soft Tissue Dissecting Time | 34 minues | Standard Deviation 19.5 |
Secondary
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.
Time frame: up to 2 weeks
Secondary
Length of Stay
number of days spent in hospital
Time frame: up to 2 weeks
Secondary
Numbers of Materials Wasted
amount of open sterile materials not used
Time frame: up to the first day post intervention
Secondary
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.
Time frame: up to the first 3 days post intervention
Secondary
Postoperative Complications
number of early wound infection
Time frame: up to 2 weeks
Secondary
Surgery Time
from the incision to the patient's sutures (minutes)
Time frame: up to the first day post intervention