Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

NCT00557947 | Completed Phase 4 Results

• 1 other identifier: 06CS005
• Study Type: interventional
• Target: 83
• Locations: 4 countries
• Sites: 5

Brief Summary

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).

Conditions

Surgical Incisions

Keywords

Abdominoplasty; Body Lift; Plastic Surgery; Skin Closure; Wound Healing; Dermabond

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Time Required to Close the Final Skin Layer

  Intraoperative

• Cosmetic Outcome

  90 days post-procedure

• Cosmetic Outcome

  6 months

• Cosmetic Outcome

  12 month

Study Arms (2)

I

EXPERIMENTAL

Dermabond Protape-Incision segments are randomized \& patient is own control

Device: Dermabond Protape (Prineo)

II

ACTIVE COMPARATOR

Intradermal Suture - Incision segments are randomized \& patient is own control. Investigator selected suture on the basis of standard local practice.

Device: Suture

Interventions

Suture DEVICE

intradermal and topical suturing

Also known as: Investigator selected the intradermal suture per standard local practice.

II

Dermabond Protape (Prineo) DEVICE

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

Also known as: Prineo

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age;
• Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
• Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
• Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study;
• Agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\];
• Sign the informed consent.

You may not qualify if:

• Have peripheral vascular disease;
• Have insulin dependent diabetes mellitus;
• Be known to have a blood clotting disorder;
• Be receiving antibiotic therapy for pre-existing condition or infection;
• Be known to be HIV-positive or otherwise immunocompromised;
• Have known personal or family history of keloid formation or hypertrophy;
• Be currently taking systemic steroids;
• Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
• Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
• Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (5)

UZ

Ghent, Belgium

Location

Dreifaltigkeits-Krankenhaus

Cologne, Germany

Location

Markus Krankenhaus

Frankfurt, Germany

Location

Akademikliniken

Stockholm, Sweden

Location

Mid Essex Hospital

Broomfield, Essex, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

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.

Results Point of Contact

• Title: John Lombard
• 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 14, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2009
• Last Updated: July 19, 2012
• Results First Posted: July 19, 2012

Record last verified: 2012-06

Locations

GB (1); BE (1); SE (1); DE (2)