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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Dermabond Protape-Incision segments are randomized & patient is own control |
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| II | Active Comparator | Intradermal Suture - Incision segments are randomized & patient is own control. Investigator selected suture on the basis of standard local practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture | Device | intradermal and topical suturing |
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| 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 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%. | 12-25 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Time Required to Close the Final Skin Layer | Time to close final skin layer for each incision segment. | 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 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. |
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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 general population undergoing elective surgical procedures for body contouring.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 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%. | The primary analysis is based upon intent to treat population. | Posted | Number | Participants | 12-25 days post-operation |
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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 | Dermabond Protape | Dermabond Protape-Incision segments are randomized & patient is own control |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Dehiscence | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Subject experienced wound dehiscence due to an infection. No action taken regarding device. The event was not related to the sutures, possibly related to the DERMABOND PROTAPE, and definitely related to the procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (General Disorders) | General disorders | MedDRA (10.0) | Systematic Assessment | Pain at application site. |
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 | |
|---|---|---|---|---|
| John Lombard | Ethicon Inc | 908-218-2877 | Jlombar8@its.jnj.com |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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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| Dermabond Protape (Prineo) | Device | cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive |
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| 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 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. | 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 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. | 12 month |
| Cologne |
| Germany |
| Markus Krankenhaus | Frankfurt | Germany |
| Akademikliniken | Stockholm | Sweden |
| Mid Essex Hospital | Broomfield | Essex | United Kingdom |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Suture - Incision segments are randomized & patient is own control.
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| Secondary | Time Required to Close the Final Skin Layer | Time to close final skin layer for each incision segment. | The analysis is based upon the Intent To Treat population | Posted | Mean | Standard Deviation | minutes | Intraoperative |
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| 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. | There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome. | Posted | Number | Incisions with good outcome | 90 days post-procedure |
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| 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. | There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome. | Posted | Number | Incisions with good outcomes | 6 months |
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| 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. | There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome. | Posted | Number | Incisions with good outcome | 12 month |
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| 3 |
| 83 |
| 16 |
| 83 |
| EG001 | Suture | Suture - Incision segments are randomized & patient is own control. | 3 | 83 | 16 | 83 |
| EG002 | Procedure | 11 | 83 | 24 | 83 |
| EG003 | Unrelated | Reported events per local regulatory requirements but not related to either device or procedure. | 3 | 83 | 7 | 83 |
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| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment | The subject experienced an infection and seroma. There was no action taken regarding the study device, The infection was classified as not related to either the sutures or the DERMABOND PROTAPE, but was definitely related to the procedure. |
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| Seroma | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | The subject experienced an infection and seroma. There was no action taken regarding the study device, The seroma was classified as not related to either the sutures or the DERMABOND PROTAPE but was definitely related to the procedure. |
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| Wound Necrosis | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Subject experienced wound necrosis requiring surgical treatment. No action required with respect to device. The event was classified as not related to INTRADRERMAL SUTURES or the DERMABOND PROTAPE, but was definitely related to the procedure. |
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| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Subject experienced infection and seroma. No action was taken with device. The infjection was assessed as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure. |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | The subject experienced an infection and seroma. No action was taken regarding the study device for either device. The seroma was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure. |
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| Chest Pain | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Subject experienced chest pain. No action was taken with study device. The event was classified as not related to sutures, DERMABOND PROTAPE, or the procedure. |
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| Metastic Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment | The subject died of metastatic breast cancer. In the opinion of the investigator, the event was classified as not related to either the study device/procedure. |
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| Procedural Complication (requiring removal of skin flap) due to congestion of blood supply | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | Subject required required removal of the flap due to congestion of blood supply.There was no action taken regarding study device. Te event was classified as not related to the suture OR DERMABOND ROTAPE, but definitely related to the procedure. |
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| Fluid Overload | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | During surgery, the subject experienced fluid overload (fluid induced respiratory depression). No action was taken with study device. The event was classified as not related to sutures or DERMABOND PROTAPE, and definitely related to the procedure |
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| Hematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment | The subject experienced hematoma and dehiscence. No action was taken with device with respect to hematoma. The event was no related to sutures or DERMABOND PROTAPE, and definitely related to the procedure. |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | The subject experienced hematoma and dehiscence. No action was taken with device with respect to dehiscence. The event was no related to sutures or DERMABOND PROTAPE, and definitely related to the procedure. |
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| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as possibly related to sutures and DERMABOND PROTAPE and as definitely related to the procedure. |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as related to sutures, possibly related to DERMABOND PROTAPE, and definitely related to the procedure |
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| Hematoma | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Subject experienced hematoma, infection and dehiscence following treatment. No action was taken with devices for the events. The hematoma was classified as possibly related to sutures and DERMABOND PROTAPE, and definitely related to the procedure. |
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| Wound Infection | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | The subject experienced wound infection (DERMABOND PROTAPE side). No was action taken regarding the study device. The event was classified as not related to sutures, definitely related to DERMABOND PROTAPE, and possibly related to the procedure. |
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| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | The subject experienced arrhythmia (Tachycardia) and breast abscess. No action taken regarding the study device with respect to arrythmia. The event was classified as not related to sutures or DERMABOND PROTAPE, and possibly related to the procedure. |
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| Breast Abcess | Infections and infestations | MedDRA (10.0) | Systematic Assessment | The subject experienced arrhythmia (Tachycardia) and breast abscess. No action taken regarding the study device with respect to abscess. The abscess was classified as not related to the sutures or DERMABOND PROTAPE, or the procedure. |
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| Necrosis | General disorders | MedDRA (10.0) | Systematic Assessment | The subject experienced necrosis (blood supply problem to breast reconstruction) requiring device removal.The event was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to procedure |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Nausea experienced following surgery. |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Insomnia experienced following surgery. |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Procedure Pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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