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Wounds and InjuriesNCT03688880

A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

A study testing MAR-CUTIS and Dermabond Advanced in people with Wounds and Injuries and Lacerations, run by Grünenthal GmbH at 19 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
What is being tested?
MAR-CUTIS and Dermabond Advanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
19 sitesin 4 countries
Study dates
30 Oct 2018to 4 Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Investigator request.
  • Inter-current illness.

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

United Kingdom11 sites

  • 019 - Barnsley Hospital

    Barnsley, S75 2EP

  • 017 - Birmingham Children's Hospital

    Birmingham, B4 6NH

  • 018 - Bristol Royal Hospital for Children

    Bristol, BS2 8AE

  • 021 - University Hospital of Wales

    Cardiff, CF14 4XW

  • 013 - The Princess Alexandra Hospital

    Harlow, CM20 1QX

  • 011 - Leeds Teaching Hospitals

    Leeds, LS9 7TF

  • 016 - St George's Hospital

    London, SW17 0QT

  • 014 - Queen Elizabeth the Queen Mother Hospital

    Margate, CT9 4AN

  • 020 - Royal Gwent Hospital

    Newport, NP20 2UB

  • 012 - Peterborough City Hospital

    Peterborough, PE3 9GZ

  • 015 - Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Germany3 sites

  • 010 - Charité Berlin

    Berlin, 13353

  • 006 - Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • 009 - Klinikum Magdeburg

    Magdeburg, 39130

Other trials in Germany

Spain3 sites

  • 001 - Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • 022 - Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • 003 - University Hospital Virgen del Rocío

    Seville, 41013

Other trials in Spain

France2 sites

  • 004 - CHU Amiens-Picardie

    Amiens, 80054

  • 005 - Hôpital Privé Paul d'Egine

    Champigny-sur-Marne, 94500

Other trials in France

About this study

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

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.

Being tested
MAR-CUTIS, Dermabond Advanced
Keywords
Wounds, Injuries, Surgery, Lacerations, Wound healing, Surgical Wounds
Medical subject headings
Wounds and Injuries, Lacerations, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAR-CUTISDevice

    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.

  • Dermabond AdvancedDevice

    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.

Study groups in NCT03688880
Study groupRoleWhat they receive
Dermabond AdvancedActive comparatorDermabond 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.
Receives: Device: Dermabond Advanced
MAR-CUTISExperimentalMAR-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.
Receives: Device: MAR-CUTIS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Total Dehiscence of Target Wound 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").

    Measured: At Day 10

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From Baseline (Day 0) up to Month 3

Secondary outcomes (8)

  1. Number of Participants With Total Dehiscence of Target Wound at Month 1

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

    Measured: At Month 1

  2. Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)

    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.

    Measured: At Month 1 and Month 3

  3. Percentage of Participants With Wound Infections

    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.

    Measured: At Day 10, and Month 1

  4. Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)

    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.

    Measured: At Month 1 and Month 3

  5. Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale

    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.

    Measured: At Day 10 and Month 1

  6. Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire

    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.

    Measured: At Day 10 and Month 1

  7. Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire

    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.

    Measured: At Day 0 and Month 1

  8. Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire

    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).

    Measured: At Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start30 Oct 2018
  3. Primary completion17 Jul 2019
  4. Study completion4 Sep 2019

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688880
Sponsor's protocol ID
KF7021-04
Other IDs
1012937
Status last verified
Jul 2020
First submitted
26 Sep 2018
Last updated
20 Aug 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MAR-CUTIS and Dermabond Advanced in people with Wounds and Injuries and Lacerations, run by Grünenthal GmbH at 19 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, Germany, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Total Dehiscence of Target Wound at Day 10 (time frame: At Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03688880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.

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