Trial Outcomes & Findings for Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy (NCT NCT00624910)
NCT ID: NCT00624910
Last Updated: 2021-07-23
Results Overview
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
0 to 24 hours postoperatively
Results posted on
2021-07-23
Participant Flow
Participant milestones
| Measure |
Bupivacaine Sponges
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
15
|
11
|
|
Overall Study
COMPLETED
|
28
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
Baseline characteristics by cohort
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 6.17 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 42.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours postoperativelyPopulation: Intent-to-Treat Population
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Total Use of Opioid Rescue Analgesia
|
53.65 mg morphine equivalents
Standard Deviation 32.78
|
66.56 mg morphine equivalents
Standard Deviation 47.53
|
53.73 mg morphine equivalents
Standard Deviation 47.71
|
SECONDARY outcome
Timeframe: 0 to 48 hours postoperativelyPopulation: Intent-to-Treat Population
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Total Use of Opioid Rescue Analgesia
|
67.78 mg morphine equivalents
Standard Deviation 37.195
|
80.87 mg morphine equivalents
Standard Deviation 51.085
|
66.03 mg morphine equivalents
Standard Deviation 32.41
|
SECONDARY outcome
Timeframe: 0 to 72 hours postoperativelyPopulation: Intent-to-Treat Population
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Total Use of Opioid Rescue Analgesia
|
78.13 mg morphine equivalents
Standard Deviation 40.304
|
88.60 mg morphine equivalents
Standard Deviation 55.84
|
73.28 mg morphine equivalents
Standard Deviation 36.308
|
SECONDARY outcome
Timeframe: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operativelyPopulation: Intent-to-Treat Population
Pain intensity rating on a Visual Analog Scale (at rest). Lowest score possible is "0" with the highest score possible being "100". Higher number means more pain reported.
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 1.0
|
58.5 score on a scale
Standard Deviation 33.59
|
63.0 score on a scale
Standard Deviation 30.08
|
66.5 score on a scale
Standard Deviation 30.29
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 1.5
|
60.1 score on a scale
Standard Deviation 29.88
|
61.3 score on a scale
Standard Deviation 31.48
|
61.3 score on a scale
Standard Deviation 32.68
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 2.0
|
54.2 score on a scale
Standard Deviation 23.92
|
50.3 score on a scale
Standard Deviation 28.93
|
61.9 score on a scale
Standard Deviation 28.39
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 3.0
|
47.0 score on a scale
Standard Deviation 28.27
|
46.2 score on a scale
Standard Deviation 31.80
|
46.4 score on a scale
Standard Deviation 31.57
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 6.0
|
38.5 score on a scale
Standard Deviation 24.47
|
43.3 score on a scale
Standard Deviation 32.49
|
34.7 score on a scale
Standard Deviation 27.17
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 9.0
|
36.2 score on a scale
Standard Deviation 25.22
|
39.9 score on a scale
Standard Deviation 31.49
|
44.0 score on a scale
Standard Deviation 31.07
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 12
|
36.1 score on a scale
Standard Deviation 24.79
|
32.4 score on a scale
Standard Deviation 26.40
|
38.4 score on a scale
Standard Deviation 32.21
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 18
|
41.6 score on a scale
Standard Deviation 22.45
|
29.8 score on a scale
Standard Deviation 29.78
|
24.0 score on a scale
Standard Deviation 24.64
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 24
|
33.3 score on a scale
Standard Deviation 24.71
|
32.0 score on a scale
Standard Deviation 31.07
|
41.7 score on a scale
Standard Deviation 39.29
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 36
|
32.6 score on a scale
Standard Deviation 23.27
|
18.7 score on a scale
Standard Deviation 18.40
|
41.8 score on a scale
Standard Deviation 39.03
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 48
|
26.4 score on a scale
Standard Deviation 20.41
|
26.7 score on a scale
Standard Deviation 26.91
|
22.2 score on a scale
Standard Deviation 29.41
|
|
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Hour 72
|
18.6 score on a scale
Standard Deviation 16.03
|
14.7 score on a scale
Standard Deviation 17.43
|
27.7 score on a scale
Standard Deviation 29.57
|
SECONDARY outcome
Timeframe: Actual time assessed during post operative periodPopulation: Intent-to-Treat Population
Time to first use of opioid rescue analgesia - lower number means worse outcome
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Time to First Use of Opioid Rescue Analgesia
|
0.9 Time (Hours)
Interval 0.8 to 1.3
|
0.9 Time (Hours)
Interval 0.6 to 1.1
|
0.4 Time (Hours)
Interval 0.2 to 1.0
|
SECONDARY outcome
Timeframe: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operativelyPopulation: Intent-to-Treat Population
Pain intensity rating on a Visual Analog Scale (after cough). Lowest score possible is "0" with the highest score possible being "100". Higher number means more pain reported.
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 1.0
|
68.2 score on a scale
Standard Deviation 32.96
|
73.8 score on a scale
Standard Deviation 33.55
|
72.6 score on a scale
Standard Deviation 31.01
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 1.5
|
68.2 score on a scale
Standard Deviation 29.49
|
67.3 score on a scale
Standard Deviation 34.05
|
73.8 score on a scale
Standard Deviation 27.44
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 2.0
|
66.0 score on a scale
Standard Deviation 24.96
|
61.3 score on a scale
Standard Deviation 32.17
|
72.9 score on a scale
Standard Deviation 26.08
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 3.0
|
53.9 score on a scale
Standard Deviation 29.02
|
58.0 score on a scale
Standard Deviation 32.82
|
59.0 score on a scale
Standard Deviation 30.29
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 6.0
|
48.3 score on a scale
Standard Deviation 27.73
|
64.7 score on a scale
Standard Deviation 31.63
|
53.2 score on a scale
Standard Deviation 29.86
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 9.0
|
52.8 score on a scale
Standard Deviation 27.69
|
49.8 score on a scale
Standard Deviation 29.12
|
63.1 score on a scale
Standard Deviation 22.64
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 12
|
52.5 score on a scale
Standard Deviation 24.56
|
49.1 score on a scale
Standard Deviation 26.22
|
55.0 score on a scale
Standard Deviation 27.19
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 18
|
55.8 score on a scale
Standard Deviation 25.40
|
46.7 score on a scale
Standard Deviation 28.79
|
45.3 score on a scale
Standard Deviation 28.08
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 24
|
46.8 score on a scale
Standard Deviation 26.65
|
52.0 score on a scale
Standard Deviation 32.14
|
59.1 score on a scale
Standard Deviation 30.58
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 36
|
51.2 score on a scale
Standard Deviation 28.06
|
32.0 score on a scale
Standard Deviation 23.81
|
58.2 score on a scale
Standard Deviation 34.69
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 48
|
40.7 score on a scale
Standard Deviation 29.30
|
46.8 score on a scale
Standard Deviation 27.24
|
38.0 score on a scale
Standard Deviation 27.80
|
|
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Hour 72
|
28.0 score on a scale
Standard Deviation 25.97
|
28.6 score on a scale
Standard Deviation 27.94
|
40.1 score on a scale
Standard Deviation 30.85
|
SECONDARY outcome
Timeframe: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operativelyPopulation: Intent-to-Treat Population
For the 4-point categorical scale assessment, patients measured their pain intensity at rest using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 0.5
|
1.8 score on a scale
Standard Deviation 1.00
|
2.0 score on a scale
Standard Deviation 1.00
|
2.2 score on a scale
Standard Deviation 1.03
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 1.0
|
2.0 score on a scale
Standard Deviation 0.95
|
2.2 score on a scale
Standard Deviation 0.69
|
2.2 score on a scale
Standard Deviation 0.79
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 1.5
|
2.0 score on a scale
Standard Deviation 0.79
|
2.0 score on a scale
Standard Deviation 0.88
|
2.1 score on a scale
Standard Deviation 0.83
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 2.0
|
2.0 score on a scale
Standard Deviation 0.62
|
1.7 score on a scale
Standard Deviation 0.70
|
2.0 score on a scale
Standard Deviation 0.77
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 3.0
|
1.7 score on a scale
Standard Deviation 0.71
|
1.6 score on a scale
Standard Deviation 0.74
|
1.9 score on a scale
Standard Deviation 0.88
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 6.0
|
1.5 score on a scale
Standard Deviation 0.64
|
1.3 score on a scale
Standard Deviation 0.96
|
1.6 score on a scale
Standard Deviation 0.52
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 9.0
|
1.4 score on a scale
Standard Deviation 0.63
|
1.5 score on a scale
Standard Deviation 0.83
|
1.8 score on a scale
Standard Deviation 0.83
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 12
|
1.4 score on a scale
Standard Deviation 0.75
|
1.1 score on a scale
Standard Deviation 0.64
|
1.7 score on a scale
Standard Deviation 0.76
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 18
|
1.5 score on a scale
Standard Deviation 0.51
|
1.1 score on a scale
Standard Deviation 0.74
|
1.4 score on a scale
Standard Deviation 0.79
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 24
|
1.3 score on a scale
Standard Deviation 0.75
|
1.1 score on a scale
Standard Deviation 0.70
|
1.5 score on a scale
Standard Deviation 0.82
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 36
|
1.3 score on a scale
Standard Deviation 0.82
|
0.8 score on a scale
Standard Deviation 0.43
|
1.4 score on a scale
Standard Deviation 0.52
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 48
|
1.1 score on a scale
Standard Deviation 0.63
|
0.9 score on a scale
Standard Deviation 0.70
|
0.9 score on a scale
Standard Deviation 0.83
|
|
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Hour 72
|
0.9 score on a scale
Standard Deviation 0.69
|
0.6 score on a scale
Standard Deviation 0.63
|
1.1 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operativelyPopulation: Intent-to-Treat Population
For the 4-point categorical scale assessment, patients measured their pain intensity after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Outcome measures
| Measure |
Bupivacaine Sponges
n=28 Participants
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 Participants
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 Participants
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 0.5
|
2.1 score on a scale
Standard Deviation 1.02
|
2.2 score on a scale
Standard Deviation 0.83
|
2.4 score on a scale
Standard Deviation 0.84
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 1.0
|
2.2 score on a scale
Standard Deviation 0.95
|
2.5 score on a scale
Standard Deviation 0.78
|
2.4 score on a scale
Standard Deviation 0.84
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 1.5
|
2.2 score on a scale
Standard Deviation 0.83
|
2.2 score on a scale
Standard Deviation 0.80
|
2.5 score on a scale
Standard Deviation 0.69
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 2.0
|
2.2 score on a scale
Standard Deviation 0.66
|
2.0 score on a scale
Standard Deviation 0.93
|
2.3 score on a scale
Standard Deviation 0.79
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 3.0
|
2.1 score on a scale
Standard Deviation 0.80
|
2.1 score on a scale
Standard Deviation 0.88
|
2.2 score on a scale
Standard Deviation 0.79
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 6.0
|
1.8 score on a scale
Standard Deviation 0.75
|
2.1 score on a scale
Standard Deviation 0.74
|
2.1 score on a scale
Standard Deviation 0.57
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 9.0
|
1.9 score on a scale
Standard Deviation 0.74
|
2.1 score on a scale
Standard Deviation 0.80
|
2.2 score on a scale
Standard Deviation 0.67
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 12
|
1.9 score on a scale
Standard Deviation 0.91
|
1.8 score on a scale
Standard Deviation 0.69
|
2.0 score on a scale
Standard Deviation 0.58
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 18
|
1.8 score on a scale
Standard Deviation 0.73
|
1.9 score on a scale
Standard Deviation 0.74
|
1.7 score on a scale
Standard Deviation 0.76
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 24
|
1.7 score on a scale
Standard Deviation 0.76
|
1.8 score on a scale
Standard Deviation 0.77
|
1.9 score on a scale
Standard Deviation 0.57
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 36
|
1.8 score on a scale
Standard Deviation 0.87
|
1.4 score on a scale
Standard Deviation 0.76
|
1.9 score on a scale
Standard Deviation 0.74
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 48
|
1.5 score on a scale
Standard Deviation 0.84
|
1.5 score on a scale
Standard Deviation 0.92
|
1.5 score on a scale
Standard Deviation 0.69
|
|
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Hour 72
|
1.3 score on a scale
Standard Deviation 0.68
|
1.3 score on a scale
Standard Deviation 0.49
|
1.3 score on a scale
Standard Deviation 0.79
|
Adverse Events
Bupivacaine Sponges
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Collagen Sponges
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Standard of Care no Implant
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine Sponges
n=28 participants at risk
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 participants at risk
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 participants at risk
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.6%
1/28 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
0.00%
0/11 • 30 days
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Seroma
|
3.6%
1/28 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
0.00%
0/11 • 30 days
|
Other adverse events
| Measure |
Bupivacaine Sponges
n=28 participants at risk
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Collagen Sponges
n=15 participants at risk
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
|
Standard of Care no Implant
n=11 participants at risk
The patient will receive the standard of care, but no implant during surgery
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
4/28 • Number of events 4 • 30 days
|
13.3%
2/15 • Number of events 2 • 30 days
|
18.2%
2/11 • Number of events 2 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
46.4%
13/28 • Number of events 13 • 30 days
|
66.7%
10/15 • Number of events 10 • 30 days
|
45.5%
5/11 • Number of events 5 • 30 days
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
2/28 • Number of events 2 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/11 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • Number of events 5 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
18.2%
2/11 • Number of events 2 • 30 days
|
|
General disorders
Pyrexia
|
7.1%
2/28 • Number of events 2 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
27.3%
3/11 • Number of events 3 • 30 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/28 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/11 • 30 days
|
|
Investigations
Blood pressure increased
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Infections and infestations
Oxygen saturation decreased
|
0.00%
0/28 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/11 • 30 days
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/11 • 30 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/28 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/11 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
5/28 • Number of events 5 • 30 days
|
13.3%
2/15 • Number of events 2 • 30 days
|
27.3%
3/11 • Number of events 3 • 30 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • 30 days
|
0.00%
0/15 • 30 days
|
9.1%
1/11 • Number of events 1 • 30 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • 30 days
|
13.3%
2/15 • Number of events 2 • 30 days
|
0.00%
0/11 • 30 days
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place