Trial Outcomes & Findings for The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty (NCT NCT00909064)

Results Overview

Days from day of surgery to stoppage of leakage from the wound

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

Up to 10 days

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Arixtra Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Overall Study STARTED	114
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arixtra n=114 Participants Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Age, Continuous	61.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 10 days

Days from day of surgery to stoppage of leakage from the wound

Outcome measures

Outcome measures
Measure	Arixtra n=114 Participants Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Number of Days Until a Dry Wound	3.6 days Standard Deviation 2.2

SECONDARY outcome

Timeframe: Up to 10 days

Days after surgery to dischage

Outcome measures

Outcome measures
Measure	Arixtra n=114 Participants Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Number of Days in Hospital.	3.73 days Standard Deviation 1.4

SECONDARY outcome

Timeframe: Up to 10 days

Incidence of Cellulitis in patients undergoing Arixtra treatment

Outcome measures

Outcome measures
Measure	Arixtra n=114 Participants Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Incidence of Wound Infection	2 Participants

Adverse Events

Arixtra

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arixtra n=114 participants at risk Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Skin and subcutaneous tissue disorders Cellulitis	1.8% 2/114 • Number of events 2 • Length of hospital stay up to 10 days

Additional Information

Gavin Pereira

UC Davis

Phone: 916-534-0919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place