A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters
A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.
Inclusion Criteria:
For participants with surgical incisions:
Participants underwent closure of surgical incision 6 to 15 centimeters (cms) following laparotomy, abdominal hysterectomy, or laparoscopic intervention.
For participants with lacerations:
Participants requiring closure of a laceration on face (avoiding the immediate area around the eye) or extremities. In participants with multiple lacerations, one was selected as the target wound (i.e., greatest length and meets the study entry criteria).
For all participants:
Participant had given written informed consent/assent to participate.
Male and female participants at least 2 years of age and body weight 10 kilogram (kg) or greater.
Participants willing and capable of following instructions for wound care provided by the investigator and agreeing to return for all treatment control visits specified in this clinical study.
Exclusion Criteria:
For participants with lacerations:
Wounds on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips, eyes).
Wounds which might be regularly exposed to body fluids or with dense natural hair (e.g., scalp); wounds on ears.
Wounds on palms and feet.
Animal or human bites.
Lacerations that were heavily contaminated.
Punctured or crushed wounds.
Participants with lacerations having wound treatment more than 6 hours after the trauma.
For all participants:
Participants requiring suturing with sutures greater than 5 mm thickness.
Participants with documented skin disease or skin conditions (e.g., excessive hair at the site of surgery, scar tissue, wound, tattoo, coloration, or pre-existing open sores at the site of surgery that would interfere with the application of Investigational Medical Device or the skin assessment, as judged by the investigator).
Participant with any factors that might had an adverse effect on wound healing (e.g., previous history of keloid formation or hypertrophy [as well in the family]), history of immunosuppression, chronic systemic infection, or poor general health.
Participants with known blood clotting disorders.
Participants receiving steroids, immunosuppressants, chemotherapy, or anticoagulants.
Participants having known or suspected allergy or sensitivity to polyurethane, cyanoacrylates, formaldehyde, tapes or adhesives, or benzalkonium chloride.
Participant participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
Participant who was pregnant or breastfeeding.
Participant with history of a significant dermatologic disease or condition, such as atopic dermatitis, psoriasis, lichen ruber planus, vitiligo or conditions known to alter the skin appearance or physiologic response (e.g., decompensated diabetes mellitus, porphyria) that involves the investigative site.
Removal of Participants From Therapy or Assessments:
Only participants that were withdrawn from the study due to product failure at the time of application were replaced.
Participants might stop the study for any of the following reasons:
Participant request.
Use of non-permitted concurrent therapy.
Lost to follow-up (considered lost to follow-up only before Day 10).
Occurrence of adverse events not compatible with the continuation of participant participation in the study, in the investigator's opinion, or unacceptable to the participant to continue.