Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure

NCT00547638 | Completed Phase 2 Results

• 2 other identifiers: 07CS005IDE Number:G060268
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 9

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.

Conditions

Lacerations

Keywords

laceration/wound closure; topical skin adhesive

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Cosmesis

  30 days (±5 days)

Other Outcomes (4)

• The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30

  Through Day 30

• 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

• Incidence of Skin Blistering at Day 14

  Day 14

Study Arms (2)

Dermabond Protape

EXPERIMENTAL

DERMABOND PROTAPE (Prineo) Topical Skin Adhesive

Device: cyanoacrylate with pressure sensitive mesh

Dermabond HVD

ACTIVE COMPARATOR

DERMABOND HVD Topical Skin Adhesive

Device: cyanoacrylate

Interventions

cyanoacrylate with pressure sensitive mesh DEVICE

Topical Skin Adhesive

Also known as: Dermabond Protape, Prineo

Dermabond Protape

cyanoacrylate DEVICE

Topical Skin Adhesive

Also known as: Dermabond - HVD, Dermabond - Protape

Dermabond HVD

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (9)

NextCare Institute For Clinical Research

Phoenix, Arizona, 85016, United States

Location

Orlando Regional Healthcare System

Orlando, Florida, 32806, United States

Location

Investigators Research Group, LLC

Indianapolis, Indiana, 46268, United States

Location

Tulane Universtiy Hospital & Clinic

New Orleans, Louisiana, 70112, United States

Location

Stony Brook University HSC

Stony Brook, New York, 11794, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Drexel University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

The percentages of participants who withdrew prematurely from the study from each group could represent a possible study limitation.

Results Point of Contact

• Title: John Lombard, Clinical Research Manager
• Organization: Ethicon, Inc.

jlombar8@its.jnj.com

908 218 2877

Study Officials

• Helen Colquhoun, MD

  Pleiad Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 22, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-08

Locations

US (9)