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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Time Saving Techniques
• Intervention / Treatment: 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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Standard supplies used to create post-op splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Eric M Bluman, M.D., Ph.D., Brigham Foot and Ankle Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (ESTIMATE): May 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2011P002091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes