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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
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Grünenthal GmbH

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Lacerations Surgical Incision Device: MAR-CUTIS Device: Dermabond Advanced Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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.
Experimental: MAR-CUTIS
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.
 Device: MAR-CUTIS
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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").

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For participants with surgical incisions:

  1. Participants underwent closure of surgical incision 6 to 15 centimeters (cms) following laparotomy, abdominal hysterectomy, or laparoscopic intervention.

    For participants with lacerations:

  2. 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:

  3. Participant had given written informed consent/assent to participate.
  4. Male and female participants at least 2 years of age and body weight 10 kilogram (kg) or greater.
  5. 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:

  1. Wounds on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips, eyes).
  2. Wounds which might be regularly exposed to body fluids or with dense natural hair (e.g., scalp); wounds on ears.
  3. Wounds on palms and feet.
  4. Animal or human bites.
  5. Lacerations that were heavily contaminated.
  6. Punctured or crushed wounds.

  7. Participants with lacerations having wound treatment more than 6 hours after the trauma.

    For all participants:

  8. Participants requiring suturing with sutures greater than 5 mm thickness.
  9. 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).
  10. 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.
  11. Participants with known blood clotting disorders.
  12. Participants receiving steroids, immunosuppressants, chemotherapy, or anticoagulants.
  13. Participants having known or suspected allergy or sensitivity to polyurethane, cyanoacrylates, formaldehyde, tapes or adhesives, or benzalkonium chloride.
  14. Participant participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
  15. Participant who was pregnant or breastfeeding.
  16. 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:

  1. Participant request.
  2. Use of non-permitted concurrent therapy.
  3. Lost to follow-up (considered lost to follow-up only before Day 10).

  4. 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.

    • Investigator request.
    • Inter-current illness.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Grünenthal GmbH
Syneos Health
Investigators
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Study Director: Study Director Grünenthal GmbH
  Study Documents (Full-Text)

Documents provided by Grünenthal GmbH:
Study Protocol  [PDF] February 25, 2019
Statistical Analysis Plan  [PDF] October 31, 2018

More Information
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Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT03688880    
Other Study ID Numbers: KF7021-04
1012937 ( Other Identifier: Syneos Health )
First Posted: September 28, 2018    Key Record Dates
Results First Posted: August 20, 2020
Last Update Posted: August 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Grünenthal GmbH:
Wounds
Injuries
Surgery
 Lacerations
Wound healing
Surgical Wounds
Additional relevant MeSH terms:
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Surgical Wound
Lacerations
Wounds and Injuries