Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions
Condition: Surgical Incisions
MeSH terms: Surgical Wound
Intervention: Suture; Dermabond Protape (Prineo)
Intervention description: intradermal and topical suturing; cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abdominoplasty; Body Lift; Plastic Surgery; Skin Closure; Wound Healing; Dermabond

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)];

          -  Agree not to schedule any additional elective surgical procedures that involve an
             incision that is randomized for inclusion in this study, until their participation in
             this study is complete; and

          -  Sign the informed consent.

        Exclusion Criteria:

          -  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.