Trial Outcomes & Findings for Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure (NCT NCT01602484)

Results Overview

Time it takes to apply post-op splint

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)

Results posted on

2017-03-31

Participant Flow

During a six-month period from November 2011 to May 2012, fifty patients met inclusion criteria, 29 females and 21 males. Twenty-five patients were randomized to each group. The subjects were patients of the Brigham Foot and Ankle Clinic and had surgery performed at Faulkner Hospital in Boston, MA.

No enrolled patients were excluded from study or excluded from assignment to groups.

Participant milestones

Participant milestones
Measure	Splint Pack Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies Group of post-op patients who have splint applied from bulk supplies
Overall Study STARTED	25	25
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Splint Pack Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies Group of post-op patients who have splint applied from bulk supplies
Overall Study Airway issues unrelated to study	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Splint Pack n=25 Participants Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies n=25 Participants Group of post-op patients who have splint applied from bulk supplies	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	56.45 years STANDARD_DEVIATION 18.41 • n=5 Participants	56.30 years STANDARD_DEVIATION 16.81 • n=7 Participants	56.37 years STANDARD_DEVIATION 17.46 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)

Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.

Time it takes to apply post-op splint

Outcome measures

Outcome measures
Measure	Splint Pack n=25 Participants Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies n=24 Participants Group of post-op patients who have splint applied from bulk supplies
Total Splint Application Time	354 seconds Interval 341.0 to 368.0	526 seconds Interval 512.0 to 541.0

SECONDARY outcome

Timeframe: Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute)

Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.

Time it takes to gather supplies prior to splint application

Outcome measures

Outcome measures
Measure	Splint Pack n=25 Participants Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies n=24 Participants Group of post-op patients who have splint applied from bulk supplies
Time to Gather Supplies	33 seconds Interval 29.0 to 37.0	68 seconds Interval 61.0 to 76.0

SECONDARY outcome

Timeframe: 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)

Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.

Time it takes to prepare splint supplies prior to splint application

Outcome measures

Outcome measures
Measure	Splint Pack n=25 Participants Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies n=24 Participants Group of post-op patients who have splint applied from bulk supplies
Time to Prepare Splint	86 seconds Interval 80.0 to 92.0	209 seconds Interval 198.0 to 220.0

SECONDARY outcome

Timeframe: Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)

Population: One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.

Time it takes to apply splint

Outcome measures

Outcome measures
Measure	Splint Pack n=25 Participants Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack	Bulk Supplies n=24 Participants Group of post-op patients who have splint applied from bulk supplies
Time to Apply Splint	235 seconds Interval 227.0 to 244.0	249 seconds Interval 238.0 to 261.0

Adverse Events

Splint Pack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bulk Supplies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Bluman

Brigham and Women's Hospital

Phone: 6179837363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place