Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators wish to perform a randomized controlled study to determine how much time and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint packs compared to bulk supplies.
The most expensive variable in the operating room (OR) is time. At the Faulkner hospital one hour of OR time costs approximately $500, exclusive of supply and personnel costs. Many things contribute to the amount of time a surgical procedure takes. One of these is application of the post surgical immobilization required of almost all orthopedic surgery cases. Custom molded Plaster-of-Paris splints are used for immobilization after the vast majority of orthopedic foot and ankle procedures. They have many advantages including exact fit for each patient, low cost and excellent safety profile. Traditionally these splints are constructed from bulk supplies at the end of surgical cases. The collection, measurement and organization of the component materials require the circulating nurse or surgeon to devote time to these tasks. This necessarily precludes OR staff from performing other tasks in the OR and lengthens the overall case duration. By lengthening the duration of the case more cost is incurred. The total number of cases able to be completed in a single operative day may also be diminished by the aggregate increased case time. Recently, the investigators have started utilizing prepared splint packs containing all components necessary for single plaster-of-Paris splint applications. This alternative to the traditional method of splint application has minimal expense over that incurred with traditional methods. Pilot studies have shown that the use of these splint packs diminish the time of application by 50 percent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splint Pack | Experimental | Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack |
|
| Bulk Supplies | Active Comparator | Group of post-op patients who have splint applied from bulk supplies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-prepared Splint Pack composed by Medline | Device | Applying splint by using pre-prepared splint pack |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Splint Application Time | Time it takes to apply post-op splint | Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Gather Supplies | Time it takes to gather supplies prior to splint application | Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute) |
| Time to Prepare Splint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric M Bluman, M.D., Ph.D. | Brigham Foot and Ankle Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
No enrolled patients were excluded from study or excluded from assignment to groups.
During a six-month period from November 2011 to May 2012, fifty patients met inclusion criteria, 29 females and 21 males. Twenty-five patients were randomized to each group. The subjects were patients of the Brigham Foot and Ankle Clinic and had surgery performed at Faulkner Hospital in Boston, MA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Splint Pack | Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack |
| FG001 | Bulk Supplies | Group of post-op patients who have splint applied from bulk supplies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bulk splint supplies | Device | Applying splint by using the bulk splint supplies |
|
|
Time it takes to prepare splint supplies prior to splint application |
| Immediately following the operation, beginning with when medical personnel finish gathering supplies and ending when the materials are prepared to apply splint (approximately 2 minutes) |
| Time to Apply Splint | Time it takes to apply splint | Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Splint Pack | Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack |
| BG001 | Bulk Supplies | Group of post-op patients who have splint applied from bulk supplies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Total Splint Application Time | Time it takes to apply post-op splint | One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study. | Posted | Mean | 95% Confidence Interval | seconds | Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Gather Supplies | Time it takes to gather supplies prior to splint application | One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study. | Posted | Mean | 95% Confidence Interval | seconds | Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Prepare Splint | Time it takes to prepare splint supplies prior to splint application | One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study. | Posted | Mean | 95% Confidence Interval | seconds | Immediately following the operation, beginning with when medical personnel finish gathering supplies and ending when the materials are prepared to apply splint (approximately 2 minutes) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Apply Splint | Time it takes to apply splint | One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study. | Posted | Mean | 95% Confidence Interval | seconds | Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes) |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Splint Pack | Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack | 0 | 25 | 0 | 25 | ||
| EG001 | Bulk Supplies | Group of post-op patients who have splint applied from bulk supplies | 0 | 25 | 0 | 25 |
Not provided
Not provided
Splinting for one patient was interrupted secondary to airway issues unrelated to the study, so this subject was excluded from the study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Bluman | Brigham and Women's Hospital | 6179837363 | ebluman@partners.org |
| >=65 years |
|
| Male |
|
|
|
|