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

Post-operative Time Saving Techniques Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01602484
• Other study ID #: 2011P002091
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2012
• Last updated: May 17, 2012
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Post-operative Time Saving Techniques

Intervention

Device:
• Pre-prepared Splint Pack composed by Medline
Applying splint by using pre-prepared splint pack

Locations

Country	Name	City	State
United States	Faulkner Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No