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

NCT ID: NCT01602484

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Post-operative Time Saving Techniques

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Splint Pack

Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack

Group Type: EXPERIMENTAL

Pre-prepared Splint Pack composed by Medline

Intervention Type: DEVICE

Applying splint by using pre-prepared splint pack

Bulk Supplies

Group of post-op patients who have splint applied from bulk supplies

Group Type: ACTIVE_COMPARATOR

Bulk splint supplies

Intervention Type: DEVICE

Applying splint by using the bulk splint supplies

Interventions

Pre-prepared Splint Pack composed by Medline

Applying splint by using pre-prepared splint pack

Intervention Type: DEVICE

Bulk splint supplies

Applying splint by using the bulk splint supplies

Intervention Type: DEVICE

Other Intervention Names

Standard supplies used to create post-op splint

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eric Bluman

Research Director, Brigham Foot and Ankle Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric M Bluman, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham Foot and Ankle Clinic

Locations

Faulkner Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P002091

Identifier Type: -

Identifier Source: org_study_id