Trial Outcomes & Findings for Post-operative Patient Positioning Device for Improvement of Post-Operative Pain (NCT NCT04797637)
NCT ID: NCT04797637
Last Updated: 2023-08-22
Results Overview
Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
278 participants
Primary outcome timeframe
14 days postoperative
Results posted on
2023-08-22
Participant Flow
Patients who meet inclusion criteria and undergo cesarean delivery at Vanderbilt University Hospital center will be asked to participate. Informed consent will be obtained during the delivery admission. Enrolled patients will be randomized within the first 36 hours following cesarean delivery. Recruitment will occur from 4/1/2020-7/31/2021 or until enrollment target achieve.
Participant milestones
| Measure |
Treatment Group
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
The control group will have postoperative care per usual care
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
137
|
|
Overall Study
COMPLETED
|
118
|
104
|
|
Overall Study
NOT COMPLETED
|
23
|
33
|
Reasons for withdrawal
| Measure |
Treatment Group
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
The control group will have postoperative care per usual care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
32
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Post-operative Patient Positioning Device for Improvement of Post-Operative Pain
Baseline characteristics by cohort
| Measure |
Treatment Group
n=118 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
n=104 Participants
The control group will have postoperative care per usual care
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 Years
n=5 Participants
|
31 Years
n=7 Participants
|
31 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial or unknown
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Parity
|
2 Pregnancies
n=5 Participants
|
1 Pregnancies
n=7 Participants
|
2 Pregnancies
n=5 Participants
|
|
BMI at delivery
|
33 Kg/M2
n=5 Participants
|
34 Kg/M2
n=7 Participants
|
33 Kg/M2
n=5 Participants
|
|
Completed high school education or less
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Depression or anxiety
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Tobacco use in pregnancy
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior cesarean delivery
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days postoperativePostoperative analgesia will be administered to all participants as per routine guidelines on postpartum.
Outcome measures
| Measure |
Treatment Group
n=118 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
n=104 Participants
The control group will have postoperative care per usual care
|
|---|---|---|
|
Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery
|
52 Morphine milligram equivalents
Interval 15.0 to 112.0
|
68 Morphine milligram equivalents
Interval 18.0 to 112.0
|
SECONDARY outcome
Timeframe: Baseline to 14 days postoperativePostoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey. Subjective pain scores (zero to 100 sliding scale) Please provide a number that best describes pain you have experienced at its WORST since discharge? No pain (0) worst pain imaginable (100) Please provide a number that best describes the AVERAGE pain you have experienced since discharge? No pain (0) worst pain imaginable (100)
Outcome measures
| Measure |
Treatment Group
n=118 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
n=104 Participants
The control group will have postoperative care per usual care
|
|---|---|---|
|
Subjective Pain Scores During Use of Patient Positioning Device
Pain at worst
|
50 score on a scale (0-100)
Interval 27.0 to 66.0
|
51 score on a scale (0-100)
Interval 20.0 to 73.0
|
|
Subjective Pain Scores During Use of Patient Positioning Device
Average pain experienced
|
25 score on a scale (0-100)
Interval 15.0 to 35.0
|
30 score on a scale (0-100)
Interval 11.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline to 14 days postoperativePostoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey. Patient satisfaction with device Question as part of a survey to patients who had the ABBy device placed: I would use ABBy next time (strongly agree, agree, neutral, disagree, strongly disagree)
Outcome measures
| Measure |
Treatment Group
n=100 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
The control group will have postoperative care per usual care
|
|---|---|---|
|
Patient Satisfaction During Use of Patient Positioning Device.
Neutral
|
24 Participants
|
—
|
|
Patient Satisfaction During Use of Patient Positioning Device.
Strongly disagree
|
1 Participants
|
—
|
|
Patient Satisfaction During Use of Patient Positioning Device.
Strongly agree
|
30 Participants
|
—
|
|
Patient Satisfaction During Use of Patient Positioning Device.
Agree
|
33 Participants
|
—
|
|
Patient Satisfaction During Use of Patient Positioning Device.
Disagree
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 days postoperativePostoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey. Duration of use of patient positioning device Question on survey: How long did you use the ABBy? (please enter a number of days, counting from the day placed as zero)
Outcome measures
| Measure |
Treatment Group
n=63 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
The control group will have postoperative care per usual care
|
|---|---|---|
|
Duration of Use of Patient Positioning Device.
|
5 Days
Interval 3.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 daysSpecific medical information regarding pregnancy and delivery will be collected and analyzed from the patients' electronic medical records.
Outcome measures
| Measure |
Treatment Group
n=118 Participants
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
n=104 Participants
The control group will have postoperative care per usual care
|
|---|---|---|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
postpartum hemorrhage
|
0 Participants
|
0 Participants
|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
6. Postpartum preeclampsia
|
3 Participants
|
2 Participants
|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
endometritis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
Problems with the incision healing
|
2 Participants
|
0 Participants
|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
mastitis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
venous thromboembolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: Due to the inability to achieve the necessary sample size of surgical complications, there was no data collected to analyze the costs.
Additional costs resulting from surgical complications.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=118 participants at risk
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
ABBy® Adjustable Panniculus Retractor for Wound Care: The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
|
Standard of Care
n=104 participants at risk
The control group will have postoperative care per usual care
|
|---|---|---|
|
Surgical and medical procedures
Since, discharge have you had any complications related to your delivery?
|
8.5%
10/118 • Number of events 10 • 14 days
|
5.8%
6/104 • Number of events 6 • 14 days
|
|
Surgical and medical procedures
Problems with the incision
|
1.7%
2/118 • Number of events 2 • 14 days
|
0.00%
0/104 • 14 days
|
|
Pregnancy, puerperium and perinatal conditions
Infection of the uterus
|
0.00%
0/118 • 14 days
|
1.9%
2/104 • Number of events 2 • 14 days
|
|
Pregnancy, puerperium and perinatal conditions
Breast infection
|
0.00%
0/118 • 14 days
|
0.00%
0/104 • 14 days
|
|
Blood and lymphatic system disorders
Blood clot
|
0.00%
0/118 • 14 days
|
0.00%
0/104 • 14 days
|
|
Pregnancy, puerperium and perinatal conditions
Excessive bleeding
|
0.00%
0/118 • 14 days
|
0.00%
0/104 • 14 days
|
|
Pregnancy, puerperium and perinatal conditions
Other
|
6.8%
8/118 • Number of events 8 • 14 days
|
3.8%
4/104 • Number of events 4 • 14 days
|
Additional Information
Lisa C. Zukerwise, MD
Vanderbilt University Medical Center
Phone: 9144203838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place