Surgical Incisions
Conditions
Keywords
Abdominoplasty, Body Lift, Plastic Surgery, Skin Closure, Wound Healing, Dermabond
Brief summary
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).
Interventions
DEVICESuture
intradermal and topical suturing
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
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
Yes
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; * Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift 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 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 or have participated in any clinical trial 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 post-operation | Equivalence is 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) does not exceed 12%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Close the Final Skin Layer | Intraoperative | Time to close final skin layer for each incision segment. |
| 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 incisions with good outcomes were then compared to those with poor outcomes. 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 general population undergoing elective surgical procedures for body contouring.
Participants by arm
| Arm | Count |
|---|---|
| Dermabond Protape/Suture Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied. | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | Dermabond Protape/Suture |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants |
| Region of Enrollment Belgium | 22 participants |
| Region of Enrollment Germany | 36 participants |
| Region of Enrollment Sweden | 5 participants |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 83 | 16 / 83 | 24 / 83 | 7 / 83 |
| serious Total, serious adverse events | 3 / 83 | 3 / 83 | 11 / 83 | 3 / 83 |
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 is 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) does not exceed 12%.
Time frame: 12-25 days post-operation
Population: The primary analysis is based upon intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape | 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. | 74 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. | 78 Participants |
p-value: 0.218895% CI: [0, 10.9]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 incisions with good outcomes were then compared to those with poor outcomes. 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 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape | Cosmetic Outcome | 33 Incisions with good outcome |
| Suture | Cosmetic Outcome | 37 Incisions with good outcome |
p-value: 0.3877McNemar
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 incisions with good outcomes were then compared to those with poor outcomes. 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 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape | Cosmetic Outcome | 30 Incisions with good outcomes |
| Suture | Cosmetic Outcome | 32 Incisions with good outcomes |
p-value: 0.7539McNemar
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 incisions with good outcomes were then compared to those with poor outcomes. 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 month
Population: There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape | Cosmetic Outcome | 33 Incisions with good outcome |
| Suture | Cosmetic Outcome | 32 Incisions with good outcome |
p-value: 1McNemar
Secondary
Time Required to Close the Final Skin Layer
Time to close final skin layer for each incision segment.
Time frame: Intraoperative
Population: The analysis is based upon the Intent To Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dermabond Protape | Time Required to Close the Final Skin Layer | 1.46 minutes | Standard Deviation 0.96 |
| Suture | Time Required to Close the Final Skin Layer | 6.65 minutes | Standard Deviation 4.02 |
p-value: <0.0001t-test, 2 sided