Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00914-43 | Other Identifier | ANSM (French Health Agency) Registry number for biomedical research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fovea | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TulleGras M.S. | Active Comparator | Sterile dressing that consists of viscose tissue coated with mineral vaseline |
|
| Urgotul | Active Comparator | Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgotul: Low-adherent dressing | Device |
| ||
| TulleGras M.S.: Vaseline gauze |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Healing (100% of Epithelialization). | Using photographs,independent assessor blinded assessment. | Day 21 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roger LESAUNIER, MD | Mylan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research facility ID ORG-001264 | Ajaccio | 20303 | France | |||
| Research facility ID ORG-001263 |
4 patients were not randomized Presence of clinical sign suggestive of worsened wound assessed at the randomization visit (n=4)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TulleGras M.S. | Sterile dressing that consists of viscose tissue coated with mineral vaseline TulleGras M.S.: Vaseline gauze |
| FG001 | Urgotul | Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline Urgotul: Low-adherent dressing |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Angoulême |
| 16959 |
| France |
| Research facility ORG-001090 | Athis-Mons | 91200 | France |
| Research facility ORG-001101 | Aubervilliers | 93300 | France |
| Research facility ID ORG-001099 | Carpentras | 84200 | France |
| Research facility ORG-001099 | Carpentras | 84200 | France |
| Research facility ORG-001107 | Cornebarrieu | 31700 | France |
| Research facility ID ORG-001223 | La Rochelle | 17000 | France |
| Research facility ORG-001096 | Levallois-Perret | 92300 | France |
| Research facility ID ORG-001276 | Lille | 59037 | France |
| Research facility ORG-001102 | Lille | 59037 | France |
| Research facility ORG-001360 | Lyon | 69003 | France |
| Research facility ORG-001132 | Mantes-la-Jolie | 78200 | France |
| Research facility ID ORG-001133 | Montpellier | 34295 | France |
| Research facility ORG-001133 | Montpellier | 34295 | France |
| Research facility ID ORG-001220 | Montreuil | 93105 | France |
| Research facility ID ORG-001189 | Nice | 6002 | France |
| Research facility ID ORG-001190 | Ollioules | 89190 | France |
| Research facility ID ORG-001088 | Paris | 75008 | France |
| Research facility ID ORG-001105 | Paris | 75008 | France |
| Research facility ORG-001105 | Paris | 75008 | France |
| Research facility ID ORG-001134 | Paris | 75014 | France |
| Research facility ID ORG-001265 | Paris | 75014 | France |
| Research facility ORG-001088 | Paris | 75018 | France |
| Research facility ID ORG-001221 | Paris | 75877 | France |
| Research facility ORG-001166 | Pierre-Bénite | 69495 | France |
| Research facility ID ORG-001278 | Reims | 51090 | France |
| Research facility ORG-001137 | Roubaix | 59100 | France |
| Research facility ORG-001136 | Rouen | 76000 | France |
| Research facility ORG-001089 | Saint-Nazaire | 44600 | France |
| Research facility ID ORG-001222 | Sarreguemines | 57200 | France |
| Research facility ORG-001097 | Sarreguemines | 57200 | France |
| Research facility ORG-001093 | Toulon | 83100 | France |
|
| Safety Population |
|
| Full Analysis Population | No efficacy assessment post-baseline (N=1) |
|
| COMPLETED | Per protocol population |
|
| NOT COMPLETED |
|
|
Full analysis population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TulleGras M.S. | Sterile dressing that consists of viscose tissue coated with mineral vaseline TulleGras M.S.: Vaseline gauze |
| BG001 | Urgotul | Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline Urgotul: Low-adherent dressing |
| 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 | Full analysis population = 203 | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Full analysis population = 203 | Count of Participants | Participants |
| |||||||||||||||
| Weight | Full analysis population = 203 Missing data = 10 | Mean | Standard Deviation | Kg |
| ||||||||||||||
| Height | Full analysis population = 203 Missing data = 10 | Mean | Standard Deviation | Cm |
| ||||||||||||||
| Body Mass Index | Full analysis population = 10 Missing data = 10 | Mean | Standard Deviation | kg/m² |
|
| 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 | Percentage of Patients With Complete Healing (100% of Epithelialization). | Using photographs,independent assessor blinded assessment. | Per protocol population | Posted | Count of Participants | Participants | Day 21 |
|
|
|
|
Not provided
Not provided
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 | TulleGras M.S. | Sterile dressing that consists of viscose tissue coated with mineral vaseline TulleGras M.S.: Vaseline gauze | 0 | 105 | 14 | 105 | 23 | 105 |
| EG001 | Urgotul | Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline Urgotul: Low-adherent dressing | 0 | 99 | 7 | 99 | 30 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| gastric fistula | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| eschereschia coli | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| pyelonephretis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| hyperthermia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| post procédural constipation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| haemorroids thrombosed | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| hypokaliaemia | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| lymphopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| prostate sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| asymptomatic cholostasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rafik NAMANE MD. | Mylan Medical SAS | 0033146258607 | rafik.namane@mylan.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
|
|