An interventional study of Pre-prepared Splint Pack composed by Medline and Bulk splint supplies in Post-operative Time Saving Techniques, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
Device: Pre-prepared Splint Pack composed by Medline
Group of post-op patients who have splint applied from bulk supplies
Device: Bulk splint supplies
Applying splint by using pre-prepared splint pack
Applying splint by using the bulk splint supplies
Also known as: Standard supplies used to create post-op splint
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)
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)
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)
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)
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.
| Milestone | Splint Pack | Bulk Supplies |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Airway issues unrelated to study | 0 | 1 |
Time it takes to apply post-op splint
| seconds | Splint Pack | Bulk Supplies |
|---|---|---|
| Total Splint Application Time | 354 (341 to 368) | 526 (512 to 541) |
Time it takes to gather supplies prior to splint application
| seconds | Splint Pack | Bulk Supplies |
|---|---|---|
| Time to Gather Supplies | 33 (29 to 37) | 68 (61 to 76) |
Time it takes to prepare splint supplies prior to splint application
| seconds | Splint Pack | Bulk Supplies |
|---|---|---|
| Time to Prepare Splint | 86 (80 to 92) | 209 (198 to 220) |
Time it takes to apply splint
| seconds | Splint Pack | Bulk Supplies |
|---|---|---|
| Time to Apply Splint | 235 (227 to 244) | 249 (238 to 261) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Splint Pack | — | 0/25 (0%) | 0/25 (0%) |
| Bulk Supplies | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Splint Pack | Bulk Supplies | Total |
|---|---|---|---|
| <=18 years | 1 | 1 | 2 |
| Between 18 and 65 years | 16 | 19 | 35 |
| >=65 years | 8 | 5 | 13 |
| Age, Continuous(years) | Splint Pack | Bulk Supplies | Total |
|---|---|---|---|
| Mean | 56.45 ± 18.41 | 56.30 ± 16.81 | 56.37 ± 17.46 |
| Sex: Female, Male(Participants) | Splint Pack | Bulk Supplies | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 10 | 11 | 21 |
| Region of Enrollment(participants) | Splint Pack | Bulk Supplies | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
Plan to share: No
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