Clinical trial NCT03688880: A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wounds and Injuries
Lacerations
Surgical Incision
Keywords: Wounds
Injuries
Surgery
Lacerations
Wound healing
Surgical Wounds
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2018-09-28
Enrollment: 107
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Total Dehiscence of Target Wound at Day 10
timeFrame: At Day 10
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From Baseline (Day 0) up to Month 3
Secondary outcomes:
measure: Number of Participants With Total Dehiscence of Target Wound at Month 1
timeFrame: At Month 1
measure: Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: At Month 1 and Month 3
measure: Percentage of Participants With Wound Infections
timeFrame: At Day 10, and Month 1
measure: Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: At Month 1 and Month 3
measure: Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale
timeFrame: At Day 10 and Month 1
measure: Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire
timeFrame: At Day 10 and Month 1
measure: Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire
timeFrame: At Day 0 and Month 1
measure: Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire
timeFrame: At Month 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: 004 - CHU Amiens-Picardie
city: Champigny-sur-Marne
country: France
facility: 005 - Hôpital Privé Paul d'Egine
city: Berlin
country: Germany
facility: 010 - Charité Berlin
city: Heidelberg
country: Germany
facility: 006 - Universitätsklinikum Heidelberg
city: Magdeburg
country: Germany
facility: 009 - Klinikum Magdeburg
city: Barcelona
country: Spain
facility: 001 - Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: 022 - Hospital General Universitario Gregorio Maranon
city: Seville
country: Spain
facility: 003 - University Hospital Virgen del Rocío
city: Barnsley
country: United Kingdom
facility: 019 - Barnsley Hospital
city: Birmingham
country: United Kingdom
facility: 017 - Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: 018 - Bristol Royal Hospital for Children
city: Cardiff
country: United Kingdom
facility: 021 - University Hospital of Wales
city: Harlow
country: United Kingdom
facility: 013 - The Princess Alexandra Hospital
city: Leeds
country: United Kingdom
facility: 011 - Leeds Teaching Hospitals
city: London
country: United Kingdom
facility: 016 - St George's Hospital
city: Margate
country: United Kingdom
facility: 014 - Queen Elizabeth the Queen Mother Hospital
city: Newport
country: United Kingdom
facility: 020 - Royal Gwent Hospital
city: Peterborough
country: United Kingdom
facility: 012 - Peterborough City Hospital
city: Taunton
country: United Kingdom
facility: 015 - Musgrove Park Hospital
Study officials:
affiliation: Grünenthal GmbH
name: Study Director
role: STUDY_DIRECTOR
References: