A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

NCT03688880 | Terminated Results FDA Device

• 2 other identifiers: KF7021-041012937
• Study Type: interventional
• Target: 107
• Locations: 4 countries
• Sites: 19

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.

Conditions

Wounds and Injuries; Lacerations; Surgical Incision

Keywords

Wounds; Injuries; Surgery; Lacerations; Wound healing; Surgical Wounds

Outcome Measures

Primary Outcomes (2)

• 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").

  At Day 10

• 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.

  From Baseline (Day 0) up to Month 3

Secondary Outcomes (8)

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

  At Month 1

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

  At Month 1 and Month 3

• Percentage of Participants With Wound Infections

  At Day 10, and Month 1

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

  At Month 1 and Month 3

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

  At Day 10 and Month 1

Study Arms (2)

Dermabond Advanced

ACTIVE COMPARATOR

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

MAR-CUTIS

EXPERIMENTAL

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

Interventions

MAR-CUTIS DEVICE

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.

MAR-CUTIS

Dermabond Advanced DEVICE

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.

Dermabond Advanced

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead
• Syneos Health: collaborator

Study Sites (19)

004 - CHU Amiens-Picardie

Amiens, 80054, France

Location

005 - Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

010 - Charité Berlin

Berlin, 13353, Germany

Location

006 - Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

009 - Klinikum Magdeburg

Magdeburg, 39130, Germany

Location

001 - Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

022 - Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

003 - University Hospital Virgen del Rocío

Seville, 41013, Spain

Location

019 - Barnsley Hospital

Barnsley, S75 2EP, United Kingdom

Location

017 - Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

018 - Bristol Royal Hospital for Children

Bristol, BS2 8AE, United Kingdom

Location

021 - University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

013 - The Princess Alexandra Hospital

Harlow, CM20 1QX, United Kingdom

Location

011 - Leeds Teaching Hospitals

Leeds, LS9 7TF, United Kingdom

Location

016 - St George's Hospital

London, SW17 0QT, United Kingdom

Location

014 - Queen Elizabeth the Queen Mother Hospital

Margate, CT9 4AN, United Kingdom

Location

020 - Royal Gwent Hospital

Newport, NP20 2UB, United Kingdom

Location

012 - Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

015 - Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Lacerations; Surgical Wound

Limitations and Caveats

The study was terminated early due to sponsor's discretion, as primary goal of the study could not be reached anymore at the time of termination.

Results Point of Contact

• Title: Grünenthal Clinical-Trials Helpdesk
• Organization: Grünenthal GmbH

clinical-trials@grunenthal.com

+49 241 569

Study Officials

• Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 30, 2018
• Primary Completion: July 17, 2019
• Study Completion: September 4, 2019
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); GB (11); DE (3); ES (3)