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| ID | Type | Description | Link |
|---|---|---|---|
| 1012937 | Other Identifier | Syneos Health |
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Sponsor decision
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Total Dehiscence of Target Wound at Month 1 | Wound dehiscence involved the breaking open of the surgical incision along the suture. | At Month 1 |
| Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
Participant participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
Participant who was pregnant or breastfeeding.
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:
Participant request.
Use of non-permitted concurrent therapy.
Lost to follow-up (considered lost to follow-up only before Day 10).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 004 - CHU Amiens-Picardie | Amiens | 80054 | France | |||
| 005 - Hôpital Privé Paul d'Egine |
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A Total of 89 participants were randomized and treated in the study. Assignment to arms was done in 2:1 ratio (MAR-CUTIS:Dermabond Advanced). Randomization was stratified by wound type (lacerations and incisions), skin type and age groups.
The study was conducted at 16 sites in 4 countries from 30 October 2018 to 04 September 2019. A total of 107 participants were enrolled of which 18 participants were screen failures. Screen failures were mainly due to inclusion criteria not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | MAR-CUTIS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2019 | Jul 10, 2020 |
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|
| 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. |
|
The POSAS was a questionnaire that was developed to assess scar quality. It consisted of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which were 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, where lower scores indicated better outcome. |
| At Month 1 and Month 3 |
| Percentage of Participants With Wound Infections | 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:
Percentage of participants with wound infections around target wound are reported. | At Day 10, and Month 1 |
| Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) | The POSAS was a questionnaire that was developed to assess scar quality. Investigator were asked to rate the severity of participant's scar compared to normal skin. The overall "opinion" ranged from 1= no pain, no itching, or normal skin to 10 = worst scar imaginable with pain and itching, where lower scores indicated better outcome. | At Month 1 and Month 3 |
| Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale | 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 reported. | At Day 10 and Month 1 |
| Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire | The questionnaire consisted of 5 yes/no questions that evaluated the participant's experience with the adhesive, 1 question that rated the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluated satisfaction with the wound closure, and visual analog scales which rate pain and scarring. | At Day 10 and Month 1 |
| Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire | The questionnaire consisted of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual analog scale that rates usability of the product from 1 (poor = very difficult to use) to 100 (excellent = very easy to use), and 1 question that evaluates satisfaction with the adhesive. | At Day 0 and Month 1 |
| Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire | The questionnaire consisted of 8 yes/no questions and 1 opinion question that evaluated the investigator's experience with use of the adhesive (i.e., instructions easy to understand, preparation of the syringe being easy and fast, glue hardening time). | At Month 1 |
| Champigny-sur-Marne |
| 94500 |
| France |
| 010 - Charité Berlin | Berlin | 13353 | Germany |
| 006 - Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| 009 - Klinikum Magdeburg | Magdeburg | 39130 | Germany |
| 001 - Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| 022 - Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| 003 - University Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| 019 - Barnsley Hospital | Barnsley | S75 2EP | United Kingdom |
| 017 - Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| 018 - Bristol Royal Hospital for Children | Bristol | BS2 8AE | United Kingdom |
| 021 - University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| 013 - The Princess Alexandra Hospital | Harlow | CM20 1QX | United Kingdom |
| 011 - Leeds Teaching Hospitals | Leeds | LS9 7TF | United Kingdom |
| 016 - St George's Hospital | London | SW17 0QT | United Kingdom |
| 014 - Queen Elizabeth the Queen Mother Hospital | Margate | CT9 4AN | United Kingdom |
| 020 - Royal Gwent Hospital | Newport | NP20 2UB | United Kingdom |
| 012 - Peterborough City Hospital | Peterborough | PE3 9GZ | United Kingdom |
| 015 - Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Analysis was performed on safety analysis set which included all participants where the application of MAR-CUTIS or Dermabond Advanced had started. Participants were analyzed under the actual treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | MAR-CUTIS | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 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 wound was held for approximately 30 seconds to allow for initial polymerization. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | Analysis was performed on Full analysis set (FAS) that included all participants randomized that were allocated to one of the 2 treatment groups and had at least 1 post-treatment assessment. | Posted | Count of Participants | Participants | At Day 10 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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. | Analysis was performed on safety analysis set that included all participants where the application of MAR-CUTIS or Dermabond Advanced had started. Participants were analyzed under the actual treatment received. | Posted | Count of Participants | Participants | From Baseline (Day 0) up to Month 3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Total Dehiscence of Target Wound at Month 1 | Wound dehiscence involved the breaking open of the surgical incision along the suture. | Study was terminated early and data was not collected for this assessment. | Posted | At Month 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) | The POSAS was a questionnaire that was developed to assess scar quality. It consisted of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which were 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, where lower scores indicated better outcome. | Study was terminated early and data was not collected for this assessment. | Posted | At Month 1 and Month 3 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Wound Infections | 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:
Percentage of participants with wound infections around target wound are reported. | Analysis was performed on FAS. | Posted | Number | percentage of participants | At Day 10, and Month 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) | The POSAS was a questionnaire that was developed to assess scar quality. Investigator were asked to rate the severity of participant's scar compared to normal skin. The overall "opinion" ranged from 1= no pain, no itching, or normal skin to 10 = worst scar imaginable with pain and itching, where lower scores indicated better outcome. | Study was terminated early and data was not collected for this assessment. | Posted | At Month 1 and Month 3 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale | 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 reported. | Analysis was performed on FAS. | Posted | Count of Participants | Participants | At Day 10 and Month 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire | The questionnaire consisted of 5 yes/no questions that evaluated the participant's experience with the adhesive, 1 question that rated the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluated satisfaction with the wound closure, and visual analog scales which rate pain and scarring. | Study was terminated early and data was not collected for this assessment. | Posted | At Day 10 and Month 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire | The questionnaire consisted of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual analog scale that rates usability of the product from 1 (poor = very difficult to use) to 100 (excellent = very easy to use), and 1 question that evaluates satisfaction with the adhesive. | Study was terminated early and data was not collected for this assessment. | Posted | At Day 0 and Month 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire | The questionnaire consisted of 8 yes/no questions and 1 opinion question that evaluated the investigator's experience with use of the adhesive (i.e., instructions easy to understand, preparation of the syringe being easy and fast, glue hardening time). | Study was terminated early and data was not collected for this assessment. | Posted | At Month 1 |
|
|
AE data was collected from Baseline until the end-of-treatment visit (Month 3).
Reported AEs and deaths are TEAEs that was defined as any adverse event that occurred during the on-treatment-period (i.e. after the start of the application of the IMD (Baseline [Day 0]) until the end-of-treatment visit (Month 3). Analysis was performed on safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 29 | 4 | 29 | 12 | 29 |
| EG001 | MAR-CUTIS | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 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 wound was held for approximately 30 seconds to allow for initial polymerization. | 1 | 60 | 13 | 60 | 31 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Faecal vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dehiscence | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound infection bacterial | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drain site complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Genital swelling | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Itching scar | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
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.
The sponsor reserves the right to review any proposed presentation of the results of this trial before they are submitted for publication or public disclosure. Neither party (e.g., the sponsor, the coordinating investigator) has the right to prohibit publication or public disclosure unless it can be shown to affect possible patent rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grünenthal Clinical-Trials Helpdesk | Grünenthal GmbH | +49 241 569 | 3223 | clinical-trials@grunenthal.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Jul 10, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D022125 | Lacerations |
| D000072836 | Surgical Wound |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 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 wound was held for approximately 30 seconds to allow for initial polymerization. |
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