A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
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| ClinicalTrials.gov Identifier: NCT03688880 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2018
Last Update Posted : November 14, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Wounds and Injuries Lacerations Surgical Incision | Device: MAR-CUTIS Device: Dermabond Advanced | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 189 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 1, 2018 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | August 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MAR-CUTIS
MAR-CUTIS is a polyurethane-based skin adhesive. At the time of use, the 2 components, prepolymer and curing agent, in the syringe are mixed in the mixing cannula. MAR-CUTIS is distributed sterile and is intended for single use.
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Device: MAR-CUTIS
MAR-CUTIS will be applied in one 1 to 2 mm thick layer, ensuring that at least 1 cm of the glue is applied over the length of the wound on each side. The amount of the glue applied will be 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 will be required. The wound will be held for approximately 30 seconds to allow for initial polymerization. |
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Active Comparator: Dermabond Advanced
Dermabond Advanced adhesive is supplied sterile, in a prefilled, single-use applicator. The pen-style applicator consists of a crushable ampoule contained within a plastic applicator. The active ingredient in Dermabond Advanced is 2-Octyl Cyanoacrylate.
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Device: Dermabond Advanced
Dermabond Advanced will be applied in 1 continuous layer onto a dry wound through painting motions, taking care not to apply adhesive between the wound edges. The wound will be held for 60 seconds to allow for complete polymerization. |
- Total dehiscence rate of the target incision/laceration at Day 10 [ Time Frame: Up to Day 10 (+/- 2 days) ]
Only one incision/laceration will be treated with the Investigational Medical Device. The total dehiscence rate of the target incision/laceration will be compared between MAR-CUTIS and Dermabond Advance.
The dehiscence will be defined as "yes" if the wound show dehiscence or "No" if the wound remains closed.
- Incidence of adverse events reported within 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]Adverse events reported within 1 month after treatment will be classified by severity and relatedness to the treatment. The incidences of mild, moderate, and severe and of related adverse events will be compared between MAR-CUTIS and Dermabond Advanced.
- Total dehiscence rate of the target incision/laceration at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]
Only one incision/laceration will be treated with the Investigational Medical Device. The total dehiscence rate of the target incision/laceration will be compared between MAR-CUTIS and Dermabond Advance.
The dehiscence will be defined as "yes" if the wound show dehiscence or "No" if the wound remains closed.
- Subject-completed Patient and Observer Scar Assessment Scale at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]To assess the subjects' satisfaction with the cosmetic outcome, subjects will complete the patient scale of the Patient and Observer Scar Assessment Scale (POSAS) at 1 month after treatment with MAR-CUTIS or Dermabond Advance. The POSAS is a questionnaire that was developed to assess scar quality. It consists of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which are 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.
- Subject-completed Patient and Observer Scar Assessment Scale at 3 months after closure of the surgical incision/laceration [ Time Frame: Up to Month 3 (+/- 14 days) ]To assess the subjects' satisfaction with the cosmetic outcome, subjects will complete the patient scale of the POSAS at 3 months after treatment with MAR-CUTIS or Dermabond Advance. The POSAS is a questionnaire that was developed to assess scar quality. It consists of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which are 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.
- Wound infection incidence at Day 10 [ Time Frame: Up to Day 10 (+/- 2 days) ]
The wound infection incidence will be assessed at the Day 10 scheduled visit (diagnosed according to the Centers for Disease Control and Prevention [CDC] criteria for surgical site infection) and will be compared between both treatment groups.
Wound infection will be assessed on a binary scale ("1 - yes" or "0 - no") for the following criteria:
- Presence of erythema
- Presence of edema
- Presence of pain at rest
- Presence of elevated temperature
A total score will be calculated for each subject.
- Wound infection incidence at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]
The wound infection incidence will be assessed at the 1-month follow-up visit (diagnosed according to the Centers for Disease Control and Prevention [CDC] criteria for surgical site infection) and will be compared between both treatment groups. Wound infection will be assessed on a binary scale ("1 - yes" or "0 - no") for the following criteria:
- Presence of erythema
- Presence of edema
- Presence of pain at rest
- Presence of elevated temperature
A total score will be calculated for each subject.
- Wound infection incidence at 3 months after closure of the surgical incision/laceration [ Time Frame: Up to Month 3 (+/- 14 days) ]
The wound infection incidence will be assessed at the Month 3 visit (diagnosed according to the Centers for Disease Control and Prevention [CDC] criteria for surgical site infection) and will be compared between both treatment groups.
Wound infection will be assessed on a binary scale ("1 - yes" or "0 - no") for the following criteria:
- Presence of erythema
- Presence of edema
- Presence of pain at rest
- Presence of elevated temperature
A total score will be calculated for each subject.
- Investigator-completed Patient and Observer Scar Assessment Scale at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]To assess the medical practitioner satisfaction with the cosmetic outcome, the investigator will complete the observer scale of the POSAS after 1 month of treatment with MAR-CUTIS or Dermabond Advance. The POSAS is a questionnaire that was developed to assess scar quality. It consists of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which are 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.
- Investigator-completed Patient and Observer Scar Assessment Scale at 3 months after closure of the surgical incision/laceration [ Time Frame: Up to Month 3 (+/- 14 days) ]To assess the medical practitioner satisfaction with the cosmetic outcome, the Investigator will complete the observer score of the POSAS at 3 months after treatment with MAR-CUTIS or Dermabond Advance. The POSAS is a questionnaire that was developed to assess scar quality. It consists of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which are 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.
- Investigator-completed Modified Hollander Cosmesis Scale at Day 10 [ Time Frame: Up to Day 10 (+/- 2 days) ]The investigator's satisfaction with the cosmetic outcome will be assessed using the Modified Hollander Cosmesis Scale (mHCS). The mHCS consists of 6 wound characteristics, evaluated as "poor" or "good". Each of the characteristics is graded on a 0 (no/good) or 1 (yes/poor) point scale. A total cosmetic score is derived by the addition of the scores.
- Investigator-completed Modified Hollander Cosmesis Scale at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]The investigator's satisfaction with the cosmetic outcome will be assessed using the mHCS. The mHCS consists of 6 wound characteristics, evaluated as "poor" or "good". Each of the characteristics is graded on a 0 (no/good) or 1 (yes/poor) point scale. A total cosmetic score is derived by the addition of the scores.
- Subject comfort with the device at Day 10 [ Time Frame: Up to Day 10 (+/- 2 days) ]A questionnaire related to subject experience and satisfaction with the treatment they received will be used. The questionnaire consists of 5 yes/no questions that evaluate the subject's experience with the adhesive, 1 question that rates the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluates satisfaction with the wound closure, and visual analog scales which rate pain and scarring.
- Subject comfort with the device at 1 month after closure of the surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]A questionnaire related to subject experience and satisfaction with the treatment they received will be used. The questionnaire consists of 5 yes/no questions that evaluate the subject's experience with the adhesive, 1 question that rates the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluates satisfaction with the wound closure, and visual analog scales which rate pain and scarring.
- Medical practitioner overall satisfaction and ease of use with the device during and after the closure of the target surgical incision/laceration [ Time Frame: Up to Month 1 (+/- 7 days) ]A questionnaire for investigators will be completed at the Month 1 visit. This questionnaire consists of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual scale that rates the usability of the product from 1 to 100, and 1 question that evaluates satisfaction with the adhesive.
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| Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For subjects with surgical incisions:
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Subject undergoing closure of surgical incision 6 to 15 centimeters following laparotomy, abdominal hysterectomy, or laparoscopic intervention.
For subjects with lacerations:
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Subject requiring closure of a laceration on face (avoiding the immediate area around the eye) or extremities. In subjects with multiple lacerations, one will be selected as the target wound (i.e., greatest length and meets the study entry criteria).
For all subjects:
- Subject has given written informed consent/assent to participate.
- Male and female subjects at least 2 years of age and body weight 10 kg or greater.
- Subject 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 subjects with lacerations:
- Wounds on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips, eyes).
- Wounds which may 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 are heavily contaminated.
- Punctured or crushed wounds.
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Subjects with lacerations having wound treatment more than 6 hours after the trauma.
For all subjects:
- Subjects requiring suturing with sutures greater than 5 mm thickness.
- Subject 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).
- Subject with any factors that may have 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.
- Subjects with known blood clotting disorders.
- Subjects receiving steroids, immunosuppressants, chemotherapy, or anticoagulants.
- Subject having known or suspected allergy or sensitivity to polyurethane, cyanoacrylates, formaldehyde, tapes or adhesives, or benzalkonium chloride.
- Subject participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
- Subject who is pregnant or breastfeeding.
- Subject 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 Subjects From Therapy or Assessments:
Only subjects that are withdrawn from the study due to product failure at the time of application will be replaced.
Subjects may stop the study for any of the following reasons:
- Subject request.
- Use of non-permitted concurrent therapy.
- Lost to follow-up (considered lost to follow-up only before Day 10).
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Occurrence of adverse events not compatible with the continuation of subject participation in the study, in the investigator's opinion, or unacceptable to the subject to continue.
- Investigator request
- Inter-current illness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688880
| Contact: Grünenthal Clinical-Trials Helpdesk | +49 (0) 241-569-3223 | clinical-trials@grunenthal.com |
| Spain | |
| 001 - Hospital Universitari Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Eloy Espin, MD | |
| Study Director: | Study Director | Grünenthal GmbH |
| Responsible Party: | Grünenthal GmbH |
| ClinicalTrials.gov Identifier: | NCT03688880 History of Changes |
| Other Study ID Numbers: |
KF7021-04 1012937 ( Other Identifier: Syneos Health ) |
| First Posted: | September 28, 2018 Key Record Dates |
| Last Update Posted: | November 14, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | Yes | |
Keywords provided by Grünenthal GmbH:
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Wounds Injuries Surgery |
Lacerations Wound healing Surgical Wounds |
Additional relevant MeSH terms:
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Surgical Wound Lacerations Wounds and Injuries |