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| ID | Type | Description | Link |
|---|---|---|---|
| IDE Number:G060268 | Other Identifier | FDA |
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This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.
According to the literature, cyanoacrylate adhesives (topical skin adhesive) have performed as intended and have not produced results that would bring into question the safety or effectiveness of cyanoacrylate adhesive for closure of surgical incisions and traumatic wounds in humans.
As such, this is a multicenter, prospective, randomized controlled study for the purpose of comparing two forms of topical skin adhesives, DERMABOND PROTAPE & DERMABOND HVD for closure of wounds in the Emergency Department.
Patients presenting in the Emergency Department with traumatic wounds meeting the acceptance criteria will have their wounds closed with DERMABOND PROTAPE or DERMABOND HVD, and will be monitored and evaluated at 14 & 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermabond Protape | Experimental | DERMABOND PROTAPE (Prineo) Topical Skin Adhesive |
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| Dermabond HVD | Active Comparator | DERMABOND HVD Topical Skin Adhesive |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyanoacrylate with pressure sensitive mesh | Device | Topical Skin Adhesive |
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| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure. | Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%. | 14 days (±2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis | The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms. | 30 days (±5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed. | Through Day 30 |
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 |
|---|---|---|---|---|---|---|
| NextCare Institute For Clinical Research | Phoenix | Arizona | 85016 | United States | ||
| Orlando Regional Healthcare System |
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Study subjects were recruited from the general population ≥1 year of age who were treated in an Emergency Department/Urgent Care Setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dermabond Protape (Prineo) | DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application. |
| FG001 | Dermabond HVD | DERMABOND HVD: Comparator tissue adhesive for topical application. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cyanoacrylate | Device | Topical Skin Adhesive |
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| The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test. | At Day 14 and Day 30 |
| Incidence of Skin Blistering at Day 14 | The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test. | Day 14 |
| Incidence of Any Other Anticipated or Unanticipated Adverse Events | Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering. | Day 30 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Investigators Research Group, LLC | Indianapolis | Indiana | 46268 | United States |
| Tulane Universtiy Hospital & Clinic | New Orleans | Louisiana | 70112 | United States |
| Stony Brook University HSC | Stony Brook | New York | 11794 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Drexel University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dermabond Protape (Prineo) | DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application |
| BG001 | Dermabond HVD | DERMABOND HVD: Comparator Tissue Adhesive for Topical Application |
| BG002 | Total | Total of all reporting groups |
| 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 | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure. | Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%. | Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation). | Posted | Number | Participants | 14 days (±2 days) |
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| Secondary | Cosmesis | The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms. | Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test. | Posted | Number | Participants | 30 days (±5 days) |
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| Other Pre-specified | The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed. | Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30. | Posted | Number | Participants | Through Day 30 |
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| Other Pre-specified | The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test. | Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint. | Posted | Number | Participants With AIRE Score >0 | At Day 14 and Day 30 |
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| Other Pre-specified | Incidence of Skin Blistering at Day 14 | The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test. | Intent to treatment population was analyzed for the incidence of skin blistering at Day 14. | Posted | Number | Participants With Blistering at Day 14 | Day 14 |
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| Other Pre-specified | Incidence of Any Other Anticipated or Unanticipated Adverse Events | Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering. | Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed. | Posted | Number | Participants Experiencing at least 1 AE | Day 30 |
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Adverse Events were collected from time of treatment out through Day 30.
The incidence of adverse events were compared between treatment groups.
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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 (Prineo) | DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application. | 0 | 143 | 0 | 143 | ||
| EG001 | Dermabond HVD | DERMABOND HVD: Comparator tissue adhesive for topical application. | 0 | 73 | 0 | 73 |
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The percentages of participants who withdrew prematurely from the study from each group could represent a possible study limitation.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Lombard, Clinical Research Manager | Ethicon, Inc. | 908 218 2877 | jlombar8@its.jnj.com |
| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| >=65 years |
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| Male |
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