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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
|
| II | Active Comparator | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabond Protape (Prineo) | Device | cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Minutes) Required to Close the Final Skin Layer | Overall time required to close final skin layer on each breast. | Intraoperative |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Colquhoun, MD | Pleiad Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ | Ghent | Belgium | ||||
| Dreifaltigkeits-Krankenhaus |
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Subjects were recruited from the genreal popluation of those undergoing elective, bilateral breast surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The primary analysis is based upon intent to treat population. | Posted | Number | Participants | 12-25 days |
|
90+/-10 days following treatment
Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prineo | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective Brachioplasty | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Subject underwent planned bilateral brachioplasty for hanging skin. The event required hospitalisation for medical/surgical intervention. In the opinion of the Investigator, the event was classified as not related to sutures or Prineo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blistering | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phyllis Britnell | Ethicon | 1 908 218-3060 | pbritnel@its.jnj.com |
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| ID | Term |
|---|---|
| C536821 | Gigantomastia |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Suture | Device | Topical Suturing |
|
|
| 90 days post-procedure |
| 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. | 6 months |
| 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. | 12 months |
| Cologne |
| Germany |
| Markus Krankenhaus | Frankfurt | Germany |
| Akademikliniken | Stockholm | Sweden |
| Mid Essex Hospital | Broomfield | Essex | United Kingdom |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
|
|
|
| Secondary | Time (Minutes) Required to Close the Final Skin Layer | Overall time required to close final skin layer on each breast. | The analysis is based upon the Intent to Treat population. | Posted | Mean | Standard Deviation | minutes | Intraoperative |
|
|
|
|
| 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. | There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome. | Posted | Number | Incisions with good outcome | 90 days post-procedure |
|
|
|
|
| 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. | There were 60 participants who completed all follow-up visits and cosmetic evaluations. | Posted | Number | Incisions with good outcome | 6 months |
|
|
|
|
| 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. | There were 59 participants who completed all follow-up visits and cosmetic evaluations. | Posted | Number | Incisions with good outcome | 12 months |
|
|
|
|
| 0 |
| 79 |
| 31 |
| 79 |
| EG001 | Suture | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. | 0 | 79 | 21 | 79 |
| EG002 | Procedure | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. | 2 | 79 | 50 | 79 |
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| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Following treatment, patient experienced postoperative sepsis and was hospitalized. Patient required surgical reintervention and was treated with antibiotics. No action was taken with respect to the study. |
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| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Itchiness at application site assessed as not related to device but to procedure. |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Nausea was assessed as not related to device but to procedure. |
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| Hematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment | Events assessed as not related to device but to procedure. |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Events assessed not related device but to procedure. |
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| Procedure Pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Open Wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
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