Trial Outcomes & Findings for Advancing the Standard of Care for Pin Site Care (NCT NCT01965665)

NCT ID: NCT01965665

Last Updated: 2016-10-31

Results Overview

total number of pin sites for all patients enrolled

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Day of surgical intervention approximately 3hrs.
• Results posted on: 2016-10-31

Participant Flow

Participant milestones

Measure	Medihoney HCS Dressing weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Advancing the Standard of Care for Pin Site Care

Baseline characteristics by cohort

Measure	Medihoney HCS Dressing n=20 Participants weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Age, Continuous	58 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgical intervention approximately 3hrs.

total number of pin sites for all patients enrolled

Outcome measures

Measure	Medihoney HCS Dressing n=19 Participants weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Total Number of Pin Sites	244 total number of pin sites

PRIMARY outcome

Timeframe: weekly from baseline until frame removal, up to 16 weeks

Patients will be assessed weekly for pin site infection up until frame removal.

Outcome measures

Measure	Medihoney HCS Dressing n=19 Participants weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Number of Patients With Pin Site Infection	3 participants

PRIMARY outcome

Timeframe: weekly from baseline until frame removal, up to 16 weeks

Population: Data not collected

Patients will be assessed weekly for sepsis or until frame is removed.

Outcome measures

Outcome data not reported

Adverse Events

Medihoney HCS Dressing

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Medihoney HCS Dressing n=19 participants at risk weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Gastrointestinal disorders GI infection	5.3% 1/19 • baseline until frame removal, up to 16 weeks

Other adverse events

Measure	Medihoney HCS Dressing n=19 participants at risk weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. MediHoney HCS dressing
Injury, poisoning and procedural complications osteotomy site infection (not pin site)	5.3% 1/19 • baseline until frame removal, up to 16 weeks

Additional Information

Michael Kerzner, DMP

Duke University Medical Center

Phone: 919-613-4449

Email: michael.kerzner@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place