Trial Outcomes & Findings for Use of a Novel Fibrin Sealant in Total Knee Arthroplasty (NCT NCT01656759)
NCT ID: NCT01656759
Last Updated: 2016-02-09
Results Overview
Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
73 participants
Primary outcome timeframe
Pre-operative to 1 month
Results posted on
2016-02-09
Participant Flow
Prior to randomization, 21 patients were disqualified for protocol violation.
Participant milestones
| Measure |
Control Group
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Control Group
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
3
|
Baseline Characteristics
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Control Group
n=25 Participants
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=22 Participants
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 9 • n=99 Participants
|
64 years
STANDARD_DEVIATION 10 • n=107 Participants
|
66 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
22 participants
n=107 Participants
|
47 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-operative to 1 monthPre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.
Outcome measures
| Measure |
Control Group
n=25 Participants
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=22 Participants
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Primary--Percent Change of Pre- to Post-Operative Hemoglobin
|
20.1 Percent Change
Standard Deviation 7.0
|
22.5 Percent Change
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Collected during surgery and in first 2-3 days after surgeryCombination of intraoperative and postoperative blood loss for participants.
Outcome measures
| Measure |
Control Group
n=25 Participants
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=22 Participants
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Total Blood Loss
|
605 mL
Standard Deviation 288
|
621 mL
Standard Deviation 334
|
SECONDARY outcome
Timeframe: 3 daysThe number of transfusions each patient receives during their postoperative hospitalization.
Outcome measures
| Measure |
Control Group
n=25 Participants
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=22 Participants
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Total Transfusions
|
3 Number of transfusions
|
3 Number of transfusions
|
SECONDARY outcome
Timeframe: 3 daysMeasured as drainage output from postoperative drains during hospitalization.
Outcome measures
| Measure |
Control Group
n=25 Participants
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=22 Participants
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Postoperative Blood Loss
|
543 mL
Standard Deviation 273
|
555 mL
Standard Deviation 324
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Group--Evicel Fibrin Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=27 participants at risk
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=25 participants at risk
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/27
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.00%
0/27
|
0.00%
0/25
|
Other adverse events
| Measure |
Control Group
n=27 participants at risk
Control group. Will not receive the fibrin spray.
|
Treatment Group--Evicel Fibrin Spray
n=25 participants at risk
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Superficial Wound Dehiscence
|
0.00%
0/27
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place