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Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure

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ClinicalTrials.gov Identifier: NCT01602484
Recruitment Status : Completed
First Posted : May 21, 2012
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eric Bluman, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment
Post-operative Time Saving Techniques Device: Pre-prepared Splint Pack composed by Medline Device: Bulk splint 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure
Study Start Date : October 2011
Primary Completion Date : June 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Active Comparator: Bulk Supplies
Group of post-op patients who have splint applied from bulk supplies
Device: Bulk splint supplies
Applying splint by using the bulk splint supplies
Other Name: Standard supplies used to create post-op splint



Primary Outcome Measures :
  1. 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) ]
    Time it takes to apply post-op splint


Secondary Outcome Measures :
  1. 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) ]
    Time it takes to gather supplies prior to splint application

  2. 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) ]
    Time it takes to prepare splint supplies prior to splint application

  3. 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) ]
    Time it takes to apply splint



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602484


Locations
United States, Massachusetts
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Eric M Bluman, M.D., Ph.D. Brigham Foot and Ankle Clinic

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
First Posted: May 21, 2012    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No