Efficiency of Surgical Incision Closure, Post-operative Scar
Conditions
Keywords
wound closure, prineo, scar
Brief summary
This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.
Detailed description
Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures. The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.
Interventions
DEVICEPrineo
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.
Sponsors
Ethicon, Inc.
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing Wise pattern breast reductions for symptomatic macromastia.
Exclusion criteria
* Subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the Prineo system will be excluded. * Subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time to Closure of Final Skin Layer | During operation only | This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on Patient Observer Scar Assessment Scale (POSAS) | Up to 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Score on the Vancouver Scar Scale (VSS) | Up to 1 year | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 42 |
| Total | 63 |
Baseline characteristics
| Characteristic | Prineo Closure OR Standard Suture |
|---|---|
| Age, Continuous | 37 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Operative Time to Closure of Final Skin Layer
This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
Time frame: During operation only
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prineo Closure | Operative Time to Closure of Final Skin Layer | 58.38 seconds | Standard Deviation 2.11 |
| Standard Suture | Operative Time to Closure of Final Skin Layer | 444.76 seconds | Standard Deviation 30.94 |
Secondary
Score on Patient Observer Scar Assessment Scale (POSAS)
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.
Time frame: Up to 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prineo Closure | Score on Patient Observer Scar Assessment Scale (POSAS) | 2 Weeks | 30.5 score on a scale | Standard Deviation 16.65 |
| Prineo Closure | Score on Patient Observer Scar Assessment Scale (POSAS) | 1 Year | 25 score on a scale | Standard Deviation 17.81 |
| Standard Suture | Score on Patient Observer Scar Assessment Scale (POSAS) | 2 Weeks | 32 score on a scale | Standard Deviation 15.98 |
| Standard Suture | Score on Patient Observer Scar Assessment Scale (POSAS) | 1 Year | 25.5 score on a scale | Standard Deviation 18.39 |
Other Pre-specified
Score on the Vancouver Scar Scale (VSS)
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.
Time frame: Up to 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prineo Closure | Score on the Vancouver Scar Scale (VSS) | 2 Weeks | 2.90 score on a scale | Standard Deviation 1.47 |
| Prineo Closure | Score on the Vancouver Scar Scale (VSS) | 1 Year | 2.05 score on a scale | Standard Deviation 1.04 |
| Standard Suture | Score on the Vancouver Scar Scale (VSS) | 2 Weeks | 4.1 score on a scale | Standard Deviation 1.79 |
| Standard Suture | Score on the Vancouver Scar Scale (VSS) | 1 Year | 2.2 score on a scale | Standard Deviation 1.5 |