A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

NCT ID: NCT03688880

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2019-09-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dermabond Advanced

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

MAR-CUTIS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Grünenthal GmbH

Locations

004 - CHU Amiens-Picardie

Amiens, , France

005 - Hôpital Privé Paul d'Egine

Champigny-sur-Marne, , France

010 - Charité Berlin

Berlin, , Germany

006 - Universitätsklinikum Heidelberg

Heidelberg, , Germany

009 - Klinikum Magdeburg

Magdeburg, , Germany

001 - Hospital Universitari Vall d'Hebron

Barcelona, , Spain

022 - Hospital General Universitario Gregorio Maranon

Madrid, , Spain

003 - University Hospital Virgen del Rocío

Seville, , Spain

019 - Barnsley Hospital

Barnsley, , United Kingdom

017 - Birmingham Children's Hospital

Birmingham, , United Kingdom

018 - Bristol Royal Hospital for Children

Bristol, , United Kingdom

021 - University Hospital of Wales

Cardiff, , United Kingdom

013 - The Princess Alexandra Hospital

Harlow, , United Kingdom

011 - Leeds Teaching Hospitals

Leeds, , United Kingdom

016 - St George's Hospital

London, , United Kingdom

014 - Queen Elizabeth the Queen Mother Hospital

Margate, , United Kingdom

020 - Royal Gwent Hospital

Newport, , United Kingdom

012 - Peterborough City Hospital

Peterborough, , United Kingdom

015 - Musgrove Park Hospital

Taunton, , United Kingdom

Countries

France; Germany; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1012937

Identifier Type: OTHER

Identifier Source: secondary_id

KF7021-04

Identifier Type: -

Identifier Source: org_study_id