A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

Wound dehiscence involved the breaking open of the surgical incision along the suture. Number of participants with dehiscence (reported as yes) and number of participants showing no dehiscence (reported as No).

Time frame: At Day 10

Population: Analysis was performed on Full analysis set (FAS) that included all participants randomized that were allocated to one of the 2 treatment groups and had at least 1 post-treatment assessment.

A TEAE was defined as any adverse event (AE) that occured during the on-treatment-period (i.e. after the start of the application of the Investigational Medical Device (IMD) (Day 0) until the end-of-treatment visit \[Month 3\]).This included any events related to the procedures, the IMD, or the comparator. An SAE was any untoward medical occurrence or effect that: led to death, or led to serious deterioration in the health of the participant, that either resulted in: life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent, or impairment to a body structure or a body function. Or, led to fetal distress, fetal death, or a congenital abnormality or birth defect.

Time frame: From Baseline (Day 0) up to Month 3

Population: Analysis was performed on safety analysis set that included all participants where the application of MAR-CUTIS or Dermabond Advanced had started. Participants were analyzed under the actual treatment received.

The questionnaire consisted of 8 yes/no questions and 1 opinion question that evaluated the investigator's experience with use of the adhesive (i.e., instructions easy to understand, preparation of the syringe being easy and fast, glue hardening time).

Time frame: At Month 1

Population: Study was terminated early and data was not collected for this assessment.

The investigator's satisfaction with the cosmetic outcome was assessed using the Modified Hollander Cosmesis Scale (mHCS). The mHCS consisted of 6 wound characteristics: Step-off borders, Contour irregularities, Target wound margin separation, Edge inversion, Excessive inflammation, Overall appearance. It was evaluated as poor or good. Each of the characteristics was graded on a 0 (no/good) or 1 (yes/poor) point scale, where lower score indicated better outcome. Number of participants with different wound characteristics (poor and good) and participants with missing response are also reported.

Time frame: At Day 10 and Month 1

Population: Analysis was performed on FAS.

The POSAS was a questionnaire that was developed to assess scar quality. Investigator were asked to rate the severity of participant's scar compared to normal skin. The overall opinion ranged from 1= no pain, no itching, or normal skin to 10 = worst scar imaginable with pain and itching, where lower scores indicated better outcome.

Time frame: At Month 1 and Month 3

Population: Study was terminated early and data was not collected for this assessment.

The questionnaire consisted of 5 yes/no questions that evaluated the participant's experience with the adhesive, 1 question that rated the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluated satisfaction with the wound closure, and visual analog scales which rate pain and scarring.

Time frame: At Day 10 and Month 1

Population: Study was terminated early and data was not collected for this assessment.

The questionnaire consisted of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual analog scale that rates usability of the product from 1 (poor = very difficult to use) to 100 (excellent = very easy to use), and 1 question that evaluates satisfaction with the adhesive.

Time frame: At Day 0 and Month 1

Population: Study was terminated early and data was not collected for this assessment.

The POSAS was a questionnaire that was developed to assess scar quality. It consisted of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which were scored on a 10-point rating scale. In addition, each scale has an overall opinion with 1 being no pain, no itching, or normal skin and 10 being worst scar imaginable with pain and itching, where lower scores indicated better outcome.

Time frame: At Month 1 and Month 3

Population: Study was terminated early and data was not collected for this assessment.

Wound dehiscence involved the breaking open of the surgical incision along the suture.

Time frame: At Month 1

Population: Study was terminated early and data was not collected for this assessment.

The wound infection incidence was assessed at the scheduled visits diagnosed according to the Centers for Disease Control and Prevention (CDC) criteria for surgical site infection. Wound infection was assessed and the following symptoms were evaluated if infection was present: * Presence of erythema * Presence of edema * Presence of pain at rest * Presence of elevated temperature Percentage of participants with wound infections around target wound are reported.

Time frame: At Day 10, and Month 1

Population: Analysis was performed on FAS.