Post-operative Time Saving TechniquesNCT01602484
Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure
A study testing Pre-prepared Splint Pack composed by Medline and Bulk splint supplies in people with Post-operative Time Saving Techniques, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-operative Time Saving Techniques
- What is being tested?
- Pre-prepared Splint Pack composed by Medline and Bulk splint supplies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing post-operative standard Plaster-of-Paris splint application
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Pre-prepared Splint Pack composed by Medline, Bulk splint supplies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-prepared Splint Pack composed by MedlineDevice
Applying splint by using pre-prepared splint pack
Bulk splint suppliesDevice
Also called Standard supplies used to create post-op splint
Applying splint by using the bulk splint supplies
| Study group | Role | What they receive |
|---|---|---|
| Splint Pack | Experimental | Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack Receives: Device: Pre-prepared Splint Pack composed by Medline |
| Bulk Supplies | Active comparator | Group of post-op patients who have splint applied from bulk supplies Receives: Device: Bulk splint supplies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Splint Application Time
Time it takes to apply post-op splint
Measured: Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)
Secondary outcomes (3)
Time to Gather Supplies
Time it takes to gather supplies prior to splint application
Measured: 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
Measured: 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
Measured: Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative Time Saving TechniquesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Bluman, Brigham and Women's Hospital
- Investigators
- Eric M Bluman, M.D., Ph.D., Principal investigator, Brigham Foot and Ankle Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602484
- Sponsor's protocol ID
- 2011P002091
- Status last verified
- Mar 2017
- First submitted
- 16 May 2012
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure
- ClinicalTrials.gov ID
- NCT01602484
- Acronym / sponsor ID
- 2011P002091
- Conditions
- Post-operative Time Saving Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splint Pack | Experimental | Device: Pre-prepared Splint Pack composed by MedlineGroup of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack |
| Bulk Supplies | Active comparator | Device: Bulk splint suppliesGroup of post-op patients who have splint applied from bulk supplies |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing post-operative standard Plaster-of-Paris splint application
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-prepared Splint Pack composed by MedlineApplying splint by using pre-prepared splint pack | Device | Splint Pack |
| Bulk splint suppliesAlso: Standard supplies used to create post-op splintApplying splint by using the bulk splint supplies | Device | Bulk Supplies |
Primary outcome
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
3 secondary outcomes
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 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 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Bluman, M.D., Ph.D. principal investigator
Brigham Foot and Ankle Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-prepared Splint Pack composed by Medline and Bulk splint supplies in people with Post-operative Time Saving Techniques, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.