Trial Outcomes & Findings for Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery (NCT NCT00661466)
NCT ID: NCT00661466
Last Updated: 2020-11-03
Results Overview
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
TERMINATED
PHASE2
7 participants
0 to 24 hours postoperatively
2020-11-03
Participant Flow
Study was terminated due to poor recruitment
Participant milestones
| Measure |
5x5-cm Bupivacaine Sponges
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Bupivacaine Collagen Sponge
|
5x5-cm Placebo Sponges
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
Baseline characteristics by cohort
| Measure |
5x5-cm Bupivacaine Sponges
n=4 Participants
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Bupivacaine Collagen Sponge
|
5x5-cm Placebo Sponges
n=3 Participants
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Placebo: placebo
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours postoperativelyPopulation: Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 to 48 hours postoperativelyPopulation: Study Terminated Early - Secondary end point not measured - not done
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 to 72 hours postoperativelyPopulation: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0Population: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperativelyPopulation: Study Terminated Early - Secondary end point not measured - not done
Study Terminated Early - Secondary end point not measured - not done
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0Population: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 72 hours after time 0Population: Study Terminated Early - Secondary end point not measured - not done
Study Terminated Early - Secondary end point not measured - not done
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: actual time from time 0Population: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperativelyPopulation: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 30 days after surgeryPopulation: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 72 hours post insertionPopulation: Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Outcome measures
Outcome data not reported
Adverse Events
5x5-cm Bupivacaine Sponges
5x5-cm Placebo Sponges
Serious adverse events
| Measure |
5x5-cm Bupivacaine Sponges
n=4 participants at risk
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Bupivacaine Collagen Sponge
|
5x5-cm Placebo Sponges
n=3 participants at risk
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Placebo: placebo
|
|---|---|---|
|
Cardiac disorders
hypotension
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
Other adverse events
| Measure |
5x5-cm Bupivacaine Sponges
n=4 participants at risk
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Bupivacaine Collagen Sponge
|
5x5-cm Placebo Sponges
n=3 participants at risk
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Placebo: placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Cardiac disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Skin and subcutaneous tissue disorders
Arm Pain -IV Site
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Gastrointestinal disorders
Polyuria
|
0.00%
0/4 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Product Issues
Marcaine Sensitivity
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Cardiac disorders
Prolonged QT interval
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
General disorders
shivering
|
0.00%
0/4 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
33.3%
1/3 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
General disorders
elevated temperature
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Surgical and medical procedures
surgical wound seroma
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
25.0%
1/4 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/3 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place