Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
|Lacerations||Device: cyanoacrylate with pressure sensitive mesh Device: cyanoacrylate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Prospective, Randomized Controlled Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Closure of Simple, Thoroughly Cleansed, Trauma-induced Wounds in the Emergency Department|
- 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. [ Time Frame: 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%.
- Cosmesis [ Time Frame: 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.
- The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
|Study Start Date:||August 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Dermabond Protape
DERMABOND PROTAPE (Prineo) Topical Skin Adhesive
Device: cyanoacrylate with pressure sensitive mesh
Topical Skin Adhesive
Active Comparator: Dermabond HVD
DERMABOND HVD Topical Skin Adhesive
Topical Skin Adhesive
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547638
|United States, Arizona|
|NextCare Institute For Clinical Research|
|Phoenix, Arizona, United States, 85016|
|United States, Florida|
|Orlando Regional Healthcare System|
|Orlando, Florida, United States, 32806|
|United States, Indiana|
|Investigators Research Group, LLC|
|Indianapolis, Indiana, United States, 46268|
|United States, Louisiana|
|Tulane Universtiy Hospital & Clinic|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Stony Brook University HSC|
|Stony Brook, New York, United States, 11794|
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|Drexel University Hospital|
|Philadelphia, Pennsylvania, United States, 19102|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Helen Colquhoun, MD||Pleiad Devices|