NCT03688880 is a NA clinical trial of MAR-CUTIS in Wounds and Injuries, sponsored by Grünenthal GmbH.

Who is sponsoring NCT03688880?

NCT03688880 is sponsored by Grünenthal GmbH.

What drugs are being tested in NCT03688880?

Interventions in NCT03688880: MAR-CUTIS, Dermabond Advanced.

What condition does NCT03688880 study?

NCT03688880 studies Wounds and Injuries, Lacerations, Surgical Incision.

Is NCT03688880 still recruiting?

NCT03688880 is currently terminated. Last updated 20 August 2020.

Are results published for NCT03688880?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-20 · How we verify

NCT03688880

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

Terminated NA Results posted Last updated 20 August 2020

What this trial tests

NA trial testing MAR-CUTIS in Wounds and Injuries in 107 participants. Terminated before completion.

Timeline

30 October 2018

Primary endpoint
17 July 2019

4 September 2019

Quick facts

Lead sponsor	Grünenthal GmbH
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	30 October 2018
Primary completion	17 July 2019
Estimated completion	4 September 2019
Sites	19 locations across France, United Kingdom, Germany, Spain

Drugs / interventions tested

MAR-CUTIS
Dermabond Advanced

Conditions studied

Wounds and Injuries — all drugs for Wounds and Injuries →
Lacerations — all drugs for Lacerations →
Surgical Incision — all drugs for Surgical Incision →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

2 and older, any sex, with Wounds and Injuries or Lacerations. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Total Dehiscence of Target Wound at Day 10 Primary · 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").

Group	Value	95% CI
Dermabond Advanced	27
MAR-CUTIS	46
Dermabond Advanced	1
MAR-CUTIS	13

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · 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

Any TEAE

Group	Value	95% CI
Dermabond Advanced	13
MAR-CUTIS	36

Any serious TEAE

Group	Value	95% CI
Dermabond Advanced	4
MAR-CUTIS	13

Any TEAE leading to withdrawal from trial

Group	Value	95% CI
Dermabond Advanced	0
MAR-CUTIS	2

Percentage of Participants With Wound Infections Secondary · 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.

Day 10

Group	Value	95% CI
Dermabond Advanced	0
MAR-CUTIS	3.4

Month 1

Group	Value	95% CI
Dermabond Advanced	0
MAR-CUTIS	3.4

Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale Secondary · 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 repor

Day 10: Step-off borders: poor

Group	Value	95% CI
Dermabond Advanced	2
MAR-CUTIS	8

Day 10: Step-off borders: good

Group	Value	95% CI
Dermabond Advanced	22
MAR-CUTIS	47

Day 10: Step-off borders: missing

Group	Value	95% CI
Dermabond Advanced	4
MAR-CUTIS	4

Day 10: Contour irregularities: poor

Group	Value	95% CI
Dermabond Advanced	2
MAR-CUTIS	9

Day 10: Contour irregularities: good

Group	Value	95% CI
Dermabond Advanced	22
MAR-CUTIS	46

Day 10: Contour irregularities: missing

Group	Value	95% CI
Dermabond Advanced	4
MAR-CUTIS	4

Day 10: Wound margin separation: poor

Group	Value	95% CI
Dermabond Advanced	1
MAR-CUTIS	11

Day 10: Wound margin separation: good

Group	Value	95% CI
Dermabond Advanced	23
MAR-CUTIS	44

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data was collected from Baseline until the end-of-treatment visit (Month 3).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dermabond Advanced

Serious: 4/29 (14%)

Deaths: 0/29

MAR-CUTIS

Serious: 13/60 (22%)

Deaths: 1/60

Serious adverse events (21 terms)

Reaction	System	Dermabond Advanced	MAR-CUTIS
Anastomotic leak	Injury, poisoning and procedural complications	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—
Myocardial infarction	Cardiac disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Ileus paralytic	Gastrointestinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—
Abdominal abscess	Infections and infestations	—	—
Catheter site infection	Infections and infestations	—	—
Diverticulitis	Infections and infestations	—	—
Intestinal sepsis	Infections and infestations	—	—
Pelvic abscess	Infections and infestations	—	—
Postoperative wound infection	Infections and infestations	—	—
Stoma site infection	Infections and infestations	—	—
Urosepsis	Infections and infestations	—	—
Abdominal wound dehiscence	Injury, poisoning and procedural complications	—	—
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	—	—
Urinary retention postoperative	Injury, poisoning and procedural complications	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Dizziness	Nervous system disorders	—	—
Urinary retention	Renal and urinary disorders	—	—

Other adverse events (89 terms — click to expand)

Reaction	System	Dermabond Advanced	MAR-CUTIS
Abdominal pain	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Wound infection	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Tachycardia	Cardiac disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Wound	Injury, poisoning and procedural complications	—	—
Headache	Nervous system disorders	—	—
Hypoaesthesia	Nervous system disorders	—	—
Hypotension	Vascular disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Bradycardia	Cardiac disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Ocular hyperaemia	Eye disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Abdominal tenderness	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Faecal vomiting	Gastrointestinal disorders	—	—
Gastrointestinal sounds abnormal	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Haematemesis	Gastrointestinal disorders	—	—
Haematochezia	Gastrointestinal disorders	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—
Dehiscence	General disorders	—	—
Fatigue	General disorders	—	—
Oedema peripheral	General disorders	—	—
Peripheral swelling	General disorders	—	—
Swelling	General disorders	—	—
Abdominal sepsis	Infections and infestations	—	—
Bacterial infection	Infections and infestations	—	—

Most-reported serious reactions: Anastomotic leak, Wound dehiscence, Myocardial infarction, Ileus, Ileus paralytic, Intestinal obstruction, Rectal haemorrhage, Abdominal abscess.

Data from ClinicalTrials.gov NCT03688880 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Grünenthal GmbH trials

Trials by the same sponsor.

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NCT05449132 — Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the · Phase 3 · completed
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03688880 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grünenthal GmbH
Last refreshed: 20 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03688880.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing