Macromastia
Conditions
Keywords
Breast Lift, Breast Reduction, Breast Reconstruction, Plastic Surgery, Skin Closure, Wound Healing, Dermabond
Brief summary
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).
Interventions
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
DEVICESuture
Topical Suturing
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age; * Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications; * Require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure; * Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study; * Agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\]; * Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and * Sign the informed consent.
Exclusion criteria
* Have peripheral vascular disease; * Have insulin dependent diabetes mellitus; * Be known to have a blood clotting disorder; * Be receiving antibiotic therapy for pre-existing condition or infection; * Be known to be HIV-positive or otherwise immunocompromised; * Have known personal or family history of keloid formation or hypertrophy; * Be currently taking systemic steroids; * Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives * Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and * Be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups. | 12-25 days | Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (Minutes) Required to Close the Final Skin Layer | Intraoperative | Overall time required to close final skin layer on each breast. |
| Cosmetic Outcome | 90 days post-procedure | Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85. |
Countries
Belgium, Germany, Sweden, United Kingdom
Participant flow
Recruitment details
Subjects were recruited from the genreal popluation of those undergoing elective, bilateral breast surgery.
Participants by arm
| Arm | Count |
|---|---|
| Prineo and Suture On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied. | 79 |
| Total | 79 |
Baseline characteristics
| Characteristic | Prineo and Suture |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants |
| Region of Enrollment Belgium | 10 participants |
| Region of Enrollment Germany | 47 participants |
| Region of Enrollment Sweden | 16 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 79 | 21 / 79 | 50 / 79 |
| serious Total, serious adverse events | 0 / 79 | 0 / 79 | 2 / 79 |
Outcome results
Primary
Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.
Time frame: 12-25 days
Population: The primary analysis is based upon intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prineo | Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups. | 76 Participants |
| Suture | Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups. | 76 Participants |
p-value: 195% CI: [-5.9, 5.9]McNemar
Secondary
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time frame: 90 days post-procedure
Population: There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prineo | Cosmetic Outcome | 49 Incisions with good outcome |
| Suture | Cosmetic Outcome | 49 Incisions with good outcome |
p-value: 1McNemar
Secondary
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time frame: 6 months
Population: There were 60 participants who completed all follow-up visits and cosmetic evaluations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prineo | Cosmetic Outcome | 37 Incisions with good outcome |
| Suture | Cosmetic Outcome | 32 Incisions with good outcome |
p-value: 0.2266McNemar
Secondary
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time frame: 12 months
Population: There were 59 participants who completed all follow-up visits and cosmetic evaluations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prineo | Cosmetic Outcome | 40 Incisions with good outcome |
| Suture | Cosmetic Outcome | 43 Incisions with good outcome |
p-value: 0.5078McNemar
Secondary
Time (Minutes) Required to Close the Final Skin Layer
Overall time required to close final skin layer on each breast.
Time frame: Intraoperative
Population: The analysis is based upon the Intent to Treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prineo | Time (Minutes) Required to Close the Final Skin Layer | 2.56 minutes | Standard Deviation 1.34 |
| Suture | Time (Minutes) Required to Close the Final Skin Layer | 16.22 minutes | Standard Deviation 6.41 |
p-value: <0.0001t-test, 2 sided