Post-operative Time Saving Techniques
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPre-prepared Splint Pack composed by Medline
Applying splint by using pre-prepared splint pack
DEVICEBulk splint supplies
Applying splint by using the bulk splint supplies
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patient undergoing post-operative standard Plaster-of-Paris splint application
Exclusion criteria
* amputation of foot or lower limb, * procedure limited to skin or removal of superficial hardware, * BMI ≥ 40, * a medical condition that is contraindication for splint application, or * an allergy to Plaster-of-Paris
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Splint Application Time | Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes) | Time it takes to apply post-op splint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Gather Supplies | Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute) | Time it takes to gather supplies prior to splint application |
| Time to Prepare Splint | 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 it takes to prepare splint supplies prior to splint application |
| Time 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) | Time it takes to apply splint |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No enrolled patients were excluded from study or excluded from assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Splint Pack Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack | 25 |
| Bulk Supplies Group of post-op patients who have splint applied from bulk supplies | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Airway issues unrelated to study | 0 | 1 |
Baseline characteristics
| Characteristic | Bulk Supplies | Splint Pack | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 16 Participants | 35 Participants |
| Age, Continuous | 56.30 years STANDARD_DEVIATION 16.81 | 56.45 years STANDARD_DEVIATION 18.41 | 56.37 years STANDARD_DEVIATION 17.46 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Total Splint Application Time
Time it takes to apply post-op splint
Time frame: Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)
Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Splint Pack | Total Splint Application Time | 354 seconds |
| Bulk Supplies | Total Splint Application Time | 526 seconds |
Secondary
Time to Apply Splint
Time it takes to apply splint
Time frame: Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)
Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Splint Pack | Time to Apply Splint | 235 seconds |
| Bulk Supplies | Time to Apply Splint | 249 seconds |
Secondary
Time to Gather Supplies
Time it takes to gather supplies prior to splint application
Time frame: Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute)
Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Splint Pack | Time to Gather Supplies | 33 seconds |
| Bulk Supplies | Time to Gather Supplies | 68 seconds |
Secondary
Time to Prepare Splint
Time it takes to prepare splint supplies prior to splint application
Time frame: 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)
Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Splint Pack | Time to Prepare Splint | 86 seconds |
| Bulk Supplies | Time to Prepare Splint | 209 seconds |