Acute Wounds
Conditions
Brief summary
Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds
Detailed description
National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.
Interventions
DEVICELomatuell Pro
Patients will receive Lomatuell Pro dressings during 3 weeks. Lomatuell Pro® may be left in place up to 7 days; additional dressing changes can be performed as often as necessary according to the instruction for use.
DEVICEUrgoTul
Patients will receive UrgoTul dressings during 3 weeks. UrgoTul® may be left in place up to 7 days; ; additional dressing changes can be performed as often as necessary according to the instruction for use.
Sponsors
RCTs
Lohmann & Rauscher
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute wound: traumatic wound (dermabrasion, skin tears, other), small burns 1st and 2nd degree requiring the use of dressings * Acute wound size between 3 cm² and 24 cm² (wound could be covered by 2 investigational products maximum) * Wound whose duration is ≤ 3 days * Both gender with an age ≥ 18 years * Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits * Subject able to follow the protocol
Exclusion criteria
* Chronic and acute surgical wound * Infected, moderately to strongly exudative and haemorrhagic wound * Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, etc.) which as judged by the investigator could interfere with the pain assessment * Known allergy/hypersensitivity to any of the components of the investigational products * Participation in other clinical investigation within one month prior to start of investigation * Pregnant or breast-feeding women * Person protected by a legal regime (tutorship or guardianship) * Patients unable to manifest an oral consent to participate (e.g. dementia) or to understand the use of the VAS (visual analogue scale) tool * Patient not covered by health insurance/social security
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) | At Visit 2 (Day 3 ± 2 days) | To evaluate the main study objective, patients were asked to assess the pain they felt during the first dressing removal (D3±2 days) with a means of visual analog scale (VAS), a 100 mm straight line ranging from 0 to 100, where 0 refers to no pain and 100 to the worst pain imaginable. The VAS score was directly measured by the investigator with a scale in millimetres and the number was entered in the patient's case report from (CRF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Healing | At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | Percentage of epithelialization of the wound at V3 calculated based on a blind assessment of wound photographs using W.H.A.T. assessment (W.H.A.T. = Wound Healing Analysing Tool is a program for assessment of the wound photos, which allows to obtain automatically-calculated results for wound area, wound dimensions, % of necrotic, granulation or epithelium tissues in the wound bed). Complete healing was defined as 100% of the wound area covered by the epithelium. |
Countries
France
Participant flow
Recruitment details
First patient enrolled on 11 February 2019. Last patient enrolled on 16 November 2020.
Participants by arm
| Arm | Count |
|---|---|
| Lomatuell Pro Lomatuell Pro® is a wound contact layer consisting of wide-meshed tulle, impregnated with a polymer matrix, which form a gel on contact with wound exudate to facilitate moist wound healing.
Lomatuell Pro: Patients will receive Lomatuell Pro dressings during 3 weeks. Lomatuell Pro® may be left in place up to 7 days; additional dressing changes can be performed as often as necessary according to the instruction for use. | 78 |
| UrgoTul UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.
UrgoTul: Patients will receive UrgoTul dressings during 3 weeks. UrgoTul® may be left in place up to 7 days; ; additional dressing changes can be performed as often as necessary according to the instruction for use. | 81 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | complete healing by V2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | occurence of exclusion criterion | 1 | 1 |
| Overall Study | Other | 1 | 0 |
Baseline characteristics
| Characteristic | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Age, Continuous | 73.83 years STANDARD_DEVIATION 22.775 | 71.28 years STANDARD_DEVIATION 22.364 | 72.53 years STANDARD_DEVIATION 22.53 |
| BMI | 24.5 kg/m^2 STANDARD_DEVIATION 5.07 | 25.5 kg/m^2 STANDARD_DEVIATION 5.3 | 25.0 kg/m^2 STANDARD_DEVIATION 5.2 |
| Height | 165.97 cm STANDARD_DEVIATION 10.198 | 167.82 cm STANDARD_DEVIATION 9.065 | 166.9 cm STANDARD_DEVIATION 9.658 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 78 participants | 81 participants | 159 participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 83 Participants |
| Sex: Female, Male Male | 35 Participants | 41 Participants | 76 Participants |
| Weight | 67.85 kg STANDARD_DEVIATION 15.821 | 71.85 kg STANDARD_DEVIATION 14.362 | 69.86 kg STANDARD_DEVIATION 15.189 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 81 |
| other Total, other adverse events | 0 / 78 | 1 / 81 |
| serious Total, serious adverse events | 3 / 78 | 0 / 81 |
Outcome results
Primary
Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)
To evaluate the main study objective, patients were asked to assess the pain they felt during the first dressing removal (D3±2 days) with a means of visual analog scale (VAS), a 100 mm straight line ranging from 0 to 100, where 0 refers to no pain and 100 to the worst pain imaginable. The VAS score was directly measured by the investigator with a scale in millimetres and the number was entered in the patient's case report from (CRF).
Time frame: At Visit 2 (Day 3 ± 2 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lomatuell Pro | Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) | 97.4 percentage of dressing changes |
| UrgoTul | Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) | 97.5 percentage of dressing changes |
Comparison: Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.
Secondary
Complete Healing
Percentage of epithelialization of the wound at V3 calculated based on a blind assessment of wound photographs using W.H.A.T. assessment (W.H.A.T. = Wound Healing Analysing Tool is a program for assessment of the wound photos, which allows to obtain automatically-calculated results for wound area, wound dimensions, % of necrotic, granulation or epithelium tissues in the wound bed). Complete healing was defined as 100% of the wound area covered by the epithelium.
Time frame: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lomatuell Pro | Complete Healing | 48 Participants |
| UrgoTul | Complete Healing | 55 Participants |