Trial Outcomes & Findings for Use of Prineo in Breast Reduction Surgery (NCT NCT01996917)
NCT ID: NCT01996917
Last Updated: 2019-05-07
Results Overview
This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
COMPLETED
NA
21 participants
During operation only
2019-05-07
Participant Flow
21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm.
Unit of analysis: Breasts
Participant milestones
| Measure |
Prineo Closure OR Standard Suture
One breast will have skin closure with Prineo.
Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
OR
One breast will be closed in the standard fashion with suture.
|
|---|---|
|
Overall Study
STARTED
|
21 42
|
|
Overall Study
COMPLETED
|
21 42
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Prineo in Breast Reduction Surgery
Baseline characteristics by cohort
| Measure |
Prineo Closure OR Standard Suture
n=42 Breasts
One breast will have skin closure with Prineo.
Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
OR
One breast will be closed in the standard fashion with suture.
|
|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During operation onlyPopulation: 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.
This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
Outcome measures
| Measure |
Prineo Closure
n=21 Breasts
One breast will have skin closure with Prineo.
Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
|
Standard Suture
n=21 Breasts
One breast will be closed in the standard fashion with suture.
|
|---|---|---|
|
Operative Time to Closure of Final Skin Layer
|
58.38 seconds
Standard Deviation 2.11
|
444.76 seconds
Standard Deviation 30.94
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.
The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar.
Outcome measures
| Measure |
Prineo Closure
n=21 Breasts
One breast will have skin closure with Prineo.
Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
|
Standard Suture
n=21 Breasts
One breast will be closed in the standard fashion with suture.
|
|---|---|---|
|
Score on Patient Observer Scar Assessment Scale (POSAS)
2 Weeks
|
30.5 score on a scale
Standard Deviation 16.65
|
32 score on a scale
Standard Deviation 15.98
|
|
Score on Patient Observer Scar Assessment Scale (POSAS)
1 Year
|
25 score on a scale
Standard Deviation 17.81
|
25.5 score on a scale
Standard Deviation 18.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.
A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar.
Outcome measures
| Measure |
Prineo Closure
n=21 Breasts
One breast will have skin closure with Prineo.
Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
|
Standard Suture
n=21 Breasts
One breast will be closed in the standard fashion with suture.
|
|---|---|---|
|
Score on the Vancouver Scar Scale (VSS)
2 Weeks
|
2.90 score on a scale
Standard Deviation 1.47
|
4.1 score on a scale
Standard Deviation 1.79
|
|
Score on the Vancouver Scar Scale (VSS)
1 Year
|
2.05 score on a scale
Standard Deviation 1.04
|
2.2 score on a scale
Standard Deviation 1.50
|
Adverse Events
Prineo Closure OR Standard Suture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place