| Primary | Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively | | Full Analysis Set Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis. | Posted | | Mean | Standard Deviation | g/dL | | Pre-operative and 2 days post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-3.73± 1.497
- OG001-3.70± 1.205
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | one-sided, two-sample t-test | | 0.453 | | | | | | | | | | | | | No | Superiority or Other | | |
|
| Secondary | Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively | | Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels. | Posted | | Mean | Standard Deviation | g/dL | | Pre-operative and day 1 post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively | Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels. | Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels. | Posted | | Mean | Standard Deviation | g/dL | | Pre-operative and day 3 post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Hematocrit (Hct) at Postoperative Day 1 | Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels. | Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels. | Posted | | Mean | Standard Deviation | percent | | Pre-operative and day 1 post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Hematocrit (Hct) at Postoperative Day 2 | | Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels. | Posted | | Mean | Standard Deviation | percent | | Pre-operative and day 2 post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Hematocrit (Hct) at Postoperative Day 3 | | Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels. | Posted | | Mean | Standard Deviation | percent | | Pre-operative and day 3 post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Total Tourniquet Time | Measured from the time point of the tourniquet inflation to deflation using the same watch/clock | | Posted | | Mean | Standard Deviation | minutes | | Intra-operatively (on day of surgery = Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Amount of FLOSEAL Applied | | Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants | Posted | | Mean | Standard Deviation | mL | | Intra-operatively (Day 0) | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| | |
| Secondary | Duration of Surgery | | | Posted | | Mean | Standard Deviation | minutes | | Time from first incision to complete wound closure (Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Transfusion Requirements - Packed Red Blood Cells | | Full Analysis Set - participants with transfusion requirement | Posted | | Mean | Standard Deviation | mL | | Intra-operatively (Day 0) thru Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Total Drain Output at Day 1 Post-operatively | | | Posted | | Mean | Standard Deviation | mL | | 1 day post-operatively | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Pain Management - Number of Days When Pain Medication Was Used | Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis. While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary. | | Posted | | Mean | Standard Deviation | days | | Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Visual Analogue Scale (VAS) Pain Scores | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | A well-validated scale to reflect problems in people with lower limb issues.
- Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
- Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
- Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)
Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues) Postoperative (Postop) | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
|
| Secondary | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | A well-validated scale to reflect problems in people with lower limb issues.
- Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
- Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
- Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues). Postoperative (Postop) | | Posted | | Mean | Standard Deviation | score on a scale | | Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
|
| Secondary | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. | | Posted | | Mean | Standard Deviation | Scores on a scale | | Preoperative, and Postoperative Weeks 1, 2, and 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores). | | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Postoperative Weeks 1, 2, and 6 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Primary | Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) |
- Proportion of Participants who have serious injuries (SIs) related to IP
- Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP
| Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Throughout the study period, 1 year and 4 months | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Length of Hospital Stay | | | Posted | | Mean | Standard Deviation | Days | | From the day of hospitalization to the day of discharge | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression | | OG001 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. |
| |
| Secondary | Proportion of Participants With Transfusion Requirements | | Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Intra-operative | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) Including Run-In Participants | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage) | | Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6 | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) Including Run-In Participants | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery | | Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6 | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) Including Run-In Participants | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |
| Secondary | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | The number of participants responding affirmative in their rehabilitation diaries for each day | | Posted | | Number | | participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | FLOSEAL + Standard of Care (SoC) | FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression. | | OG001 | Standard of Care (SoC) | SoC: conventional hemostatic techniques such as cautery and manual compression |
| |