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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eric Bluman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01602484
First received: May 16, 2012
Last updated: May 17, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Post-operative patients undergoing standard splint application

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602484

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.         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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 July 24, 2014