Lacerations
Conditions
Keywords
laceration/wound closure, topical skin adhesive
Brief summary
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.
Detailed description
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.
Interventions
DEVICEcyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
DEVICEcyanoacrylate
Topical Skin Adhesive
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 1 year of age * in good general health in the opinion of the Investigator. * have at least one traumatic wound meeting the criteria for closure as defined in current Dermabond product labeling. * patient must be willing to follow instructions for wound care listed in device labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed. * patient agrees to return for follow-up evaluation * patient (or guardian) signs the informed consent * patient is reasonably expected to survive the study
Exclusion criteria
* significant multiple trauma (merely multiple wounds are allowed) * peripheral vascular disease * insulin dependent diabetes mellitus * known to have a blood clotting disorder * receiving antibiotic therapy for preexisting condition or infection * known to be HIV-positive or otherwise immunocompromised * known personal or family history of keloid formation or hypertrophy * currently taking systemic steroids * known allergy to cyanoacrylate, formaldehyde, tapes or adhesives * participating in another current clinical study * history of abnormal wound healing * burst stellate lacerations due to a crush or hard blow * animal or human bite or scratch * decubitus ulcer * puncture wound * wound at mucocutaneous junction or in mucosal (but not excluding the vermillion border of the lip) * wound on scalp covered by natural hair * wound has visual evidence of active infection * gangrenous wound * wound requiring debridement of devitalized or contaminated tissue * wound at site of active rash/skin lesion making evaluation difficult * previously treated wound or has failed to heal * wound in high skin tension area or across an area of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 14 days (±2 days) | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis | 30 days (±5 days) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Through 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. |
| The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | 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. |
| Incidence of Skin Blistering at Day 14 | 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. |
| Incidence of Any Other Anticipated or Unanticipated Adverse Events | Day 30 | 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. |
Countries
United States
Participant flow
Recruitment details
Study subjects were recruited from the general population ≥1 year of age who were treated in an Emergency Department/Urgent Care Setting.
Participants by arm
| Arm | Count |
|---|---|
| Dermabond Protape (Prineo) DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application | 143 |
| Dermabond HVD DERMABOND HVD: Comparator Tissue Adhesive for Topical Application | 73 |
| Total | 216 |
Baseline characteristics
| Characteristic | Dermabond HVD | Dermabond Protape (Prineo) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 52 Participants | 82 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 89 Participants | 128 Participants |
| Age Continuous | 25.7 years STANDARD_DEVIATION 19.8 | 25.0 years STANDARD_DEVIATION 18.4 | 25.2 years STANDARD_DEVIATION 18.9 |
| Region of Enrollment United States | 73 Participants | 143 Participants | 216 Participants |
| Sex: Female, Male Female | 26 Participants | 52 Participants | 78 Participants |
| Sex: Female, Male Male | 47 Participants | 91 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 143 | 0 / 73 |
| serious Total, serious adverse events | 0 / 143 | 0 / 73 |
Outcome results
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%.
Time frame: 14 days (±2 days)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape (Prineo) | 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. | 123 Participants |
| Dermabond HVD | 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. | 57 Participants |
95% CI: [-17.7, 1]Gart-Nam
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.
Time frame: 30 days (±5 days)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape (Prineo) | Cosmesis | 93 Participants |
| Dermabond HVD | Cosmesis | 43 Participants |
p-value: 0.457Fisher Exact
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.
Time frame: Day 30
Population: Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape (Prineo) | Incidence of Any Other Anticipated or Unanticipated Adverse Events | 34 Participants Experiencing at least 1 AE |
| Dermabond HVD | Incidence of Any Other Anticipated or Unanticipated Adverse Events | 10 Participants Experiencing at least 1 AE |
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.
Time frame: Day 14
Population: Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabond Protape (Prineo) | Incidence of Skin Blistering at Day 14 | 0 Participants With Blistering at Day 14 |
| Dermabond HVD | Incidence of Skin Blistering at Day 14 | 0 Participants With Blistering at Day 14 |
p-value: 1Fisher Exact
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.
Time frame: Through Day 30
Population: Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dermabond Protape (Prineo) | The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Number of Infections at Day 14 Per Group | 4 Participants |
| Dermabond Protape (Prineo) | The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Number of Infections at Day 30 Per group | 2 Participants |
| Dermabond HVD | The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Number of Infections at Day 14 Per Group | 1 Participants |
| Dermabond HVD | The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 | Number of Infections at Day 30 Per group | 0 Participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
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.
Time frame: At Day 14 and Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dermabond Protape (Prineo) | The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Participants with Total AIRE Score >0 at Day 14 | 54 Participants With AIRE Score >0 |
| Dermabond Protape (Prineo) | The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Participants with Total AIRE Score >0 at Day 30 | 55 Participants With AIRE Score >0 |
| Dermabond HVD | The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Participants with Total AIRE Score >0 at Day 14 | 35 Participants With AIRE Score >0 |
| Dermabond HVD | The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 | Participants with Total AIRE Score >0 at Day 30 | 29 Participants With AIRE Score >0 |
p-value: 0.188Fisher Exact
p-value: 0.883Fisher Exact