Surgical Acute Wounds
Conditions
Keywords
non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain
Brief summary
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
Interventions
DEVICEUrgotul: Low-adherent dressing
DEVICETulleGras M.S.: Vaseline gauze
Sponsors
Fovea
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject. * Aged 18 to 75 years * With a planned surgery: * Of abdominal location * Leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products) * Absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit) * Followed-up in surgery department * Written and signed informed consent obtained * Affiliated to the French Social Security system or equivalent.
Exclusion criteria
* Underlying pathology that may interfere with wound healing in the opinion of the Investigator (human immunodeficiency virus \[HIV\], cancer, immunodeficiency disease, generalized infection, systemic disease ...). The presence of low-risk prostate cancer according to the Amico classification (1) (PSA\<10 ng/mL and Gleason's score \< 6 and clinical grade T1c ou T2a) or a grade T1 (a or b) N0M0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria * Inadequately controlled diabetes (Glycosylated hemoglobin \> 8%) * Hypo or hyperthyroidism * Intake of a systemic treatment with glucocorticoids or immunosuppressives * Known allergy to one of study dressings components * Participation in a clinical trial in the month prior to his/her inclusion in the study * Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Complete Healing (100% of Epithelialization). | Day 21 | Using photographs,independent assessor blinded assessment. |
Countries
France
Participant flow
Pre-assignment details
4 patients were not randomized Presence of clinical sign suggestive of worsened wound assessed at the randomization visit (n=4)
Participants by arm
| Arm | Count |
|---|---|
| TulleGras M.S. Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze | 105 |
| Urgotul Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing | 98 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No efficacy assessment post-baseline | 0 | 1 |
| Overall Study | Protocol Violation | 20 | 25 |
Baseline characteristics
| Characteristic | TulleGras M.S. | Urgotul | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 13.2 | 54.4 years STANDARD_DEVIATION 14.1 | 53.4 years STANDARD_DEVIATION 13.6 |
| Body Mass Index | 29.6 kg/m² STANDARD_DEVIATION 8.3 | 28.9 kg/m² STANDARD_DEVIATION 7.2 | 29.2 kg/m² STANDARD_DEVIATION 7.8 |
| Height | 170.4 Cm STANDARD_DEVIATION 9.6 | 170.0 Cm STANDARD_DEVIATION 9.2 | 170.2 Cm STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 39 Participants | 43 Participants | 82 Participants |
| Sex: Female, Male Male | 66 Participants | 55 Participants | 121 Participants |
| Weight | 85.4 Kg STANDARD_DEVIATION 21.6 | 83.0 Kg STANDARD_DEVIATION 18.9 | 84.2 Kg STANDARD_DEVIATION 20.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 99 |
| other Total, other adverse events | 23 / 105 | 30 / 99 |
| serious Total, serious adverse events | 14 / 105 | 7 / 99 |
Outcome results
Primary
Percentage of Patients With Complete Healing (100% of Epithelialization).
Using photographs,independent assessor blinded assessment.
Time frame: Day 21
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TulleGras M.S. | Percentage of Patients With Complete Healing (100% of Epithelialization). | 77 Participants |
| Urgotul | Percentage of Patients With Complete Healing (100% of Epithelialization). | 67 Participants |