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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| custom pack | Experimental |
| |
| standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annamaria Nicolini, RN | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Care | standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Soft Tissue Dissecting Time | minutes from the start of the dissection to complete bone cleaning | Posted | Mean | Standard Deviation | minues | up to the first day post intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristiana Forni | Istituto Ortopedico Rizzoli | 0039516366 | 694 | cristiana.forni@ior.it |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D013120 | Spinal Cord Neoplasms |
| D055013 | Osteoarthritis, Spine |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard care | Other | The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery |
|
| 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 |
standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| degenerative disease | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Surgery Time | from the incision to the patient's sutures (minutes) | Not Posted | up to the first day post intervention | Participants |
| Secondary | Postoperative Complications | number of early wound infection | Not Posted | up to 2 weeks | Participants |
| Secondary | Numbers of Materials Wasted | amount of open sterile materials not used | Not Posted | up to the first day post intervention | Participants |
| 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. | Not Posted | up to 2 weeks | Participants |
| 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. | Not Posted | up to the first 3 days post intervention | Participants |
| Secondary | Length of Stay | number of days spent in hospital | Not Posted | up to 2 weeks | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Standard Care | standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery | 0 | 18 | 0 | 18 |
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| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |