A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
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|ClinicalTrials.gov Identifier: NCT03688880|
Recruitment Status : Terminated (Sponsor decision)
First Posted : September 28, 2018
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Wounds and Injuries Lacerations Surgical Incision||Device: MAR-CUTIS Device: Dermabond Advanced||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 30, 2018|
|Actual Primary Completion Date :||July 17, 2019|
|Actual Study Completion Date :||September 4, 2019|
Active Comparator: Dermabond Advanced
Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization.
Device: Dermabond Advanced
Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions, taking care not to apply adhesive between the wound edges.
MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 millimeter (mm) thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization.
MAR-CUTIS was applied in 1 to 2 mm thick layer, ensuring that at least 1 cm of the glue was applied over the length of the wound on each side. The amount of the glue applied was calculated such that one 5-mL syringe covers approximately 8 cm of wound length (giving a total of 10 cm per syringe). For wounds >8 cm, 2 syringes were required.
- Number of Participants With Total Dehiscence of Target Wound at Day 10 [ Time Frame: At Day 10 ]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").
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline (Day 0) up to Month 3 ]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.
- Number of Participants With Total Dehiscence of Target Wound at Month 1 [ Time Frame: At Month 1 ]Wound dehiscence involved the breaking open of the surgical incision along the suture.
- Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: At Month 1 and Month 3 ]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.
- Percentage of Participants With Wound Infections [ Time Frame: At Day 10, and Month 1 ]
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.
- Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: At Month 1 and Month 3 ]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.
- Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale [ Time Frame: At Day 10 and Month 1 ]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.
- Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire [ Time Frame: At Day 10 and Month 1 ]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.
- Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire [ Time Frame: At Day 0 and Month 1 ]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.
- Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire [ Time Frame: At Month 1 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688880
|Study Director:||Study Director||Grünenthal GmbH|