Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Post-operative Time Saving Techniques |
Device: Pre-prepared Splint Pack composed by Medline |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure |
- Total splint application time [ 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) ] [ Designated as safety issue: No ]Time it takes to apply post-op splint
- Time to gather supplies [ 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) ] [ Designated as safety issue: No ]Time it takes to gather supplies prior to splint application
- Time to prepare splint [ 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) ] [ Designated as safety issue: No ]Time it takes to prepare splint supplies prior to splint application
- Time 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) ] [ Designated as safety issue: No ]Time it takes to apply splint
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Splint Pack
Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
|
Device: Pre-prepared Splint Pack composed by Medline
Applying splint by using pre-prepared splint pack
|
|
Bulk Supplies
Group of post-op patients who have splint applied from 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Post-operative patients undergoing standard splint application
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
Contacts and Locations| United States, Massachusetts | |
| Faulkner Hospital | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Eric M Bluman, M.D., Ph.D. 617-983-7202 emb@partners.org | |
| Principal Investigator: Eric M Bluman, M.D., Ph.D. | |
| Sub-Investigator: Christopher P Chiodo, M.D. | |
| Sub-Investigator: David A Palms, A.B. | |
| Principal Investigator: | Eric M Bluman, M.D., Ph.D. | Brigham Foot and Ankle Clinic |
More Information
No publications provided
| Responsible Party: | Eric Bluman, Research Director, Brigham Foot and Ankle Clinic, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01602484 History of Changes |
| Other Study ID Numbers: | 2011P002091 |
| Study First Received: | May 16, 2012 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013