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| Name | Class |
|---|---|
| RCTs | INDUSTRY |
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Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds
National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lomatuell Pro | Experimental | 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. |
|
| UrgoTul | Active Comparator | UrgoTul® is a flexible contact layer with TLC (Technology Lipido-Colloid) healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lomatuell Pro | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Visit 2 (Day 3 ± 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daria TROFIMENKO | Lohmann & Rauscher | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CICA+ | Limonest | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40632070 | Result | Meaume S, Kerihuel JC, Malatesta A, Roux F, Trofimenko D, Abel M. Non-inferiority randomised controlled trial of two contact layer dressings for the treatment of acute wounds (SLALOM). J Wound Care. 2025 Jul 2;34(7):496-505. doi: 10.12968/jowc.2024.0312. |
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First patient enrolled on 11 February 2019. Last patient enrolled on 16 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | UrgoTul | UrgoTul® is a flexible contact layer with TLC (Technology Lipido-Colloid) 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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). | Posted | Number | 95% Confidence Interval | percentage of dressing changes | At Visit 2 (Day 3 ± 2 days) |
|
For each patient, adverse events were collected for maximum of 23 days from Baseline (D0) till the Final study visit (Day 21+2). There was no follow-up period in the study.
Over the safety set (159 patients), 4 patients (2.5%) experienced an adverse event (AE) during the investigation: 3 patients from the LP group and 1 patient from the UT group. All the AEs were unexpected.
All 3 AEs, registered in the LP group, were serious. The only AE, registered in the UT group, was non-serious.
None of the registered (serious) adverse events were assessed as related to the study dressing or study procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INFLAMED DIABETIC FOOT ULCER | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
Open-label investigation design (nurses and patients knew which dressing was applied); Subjective pain scores assessment (by the patients).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Daria Trofimenko, Senior Manager Clinical Regulatory Affairs | Lohmann & Rauscher GmbH & Co. KG | +49 (0) 2631 99 6385 | Daria.Trofimenko@de.LRMed.com |
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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 | Mar 29, 2019 | Aug 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2020 | Aug 30, 2023 | SAP_001.pdf |
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| UrgoTul | Device | 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. |
|
| At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) |
| complete healing by V2 |
|
| occurence of exclusion criterion |
|
| Other |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Data missing for 2 patients | Mean | Standard Deviation | kg |
|
| Height | Data missing for 2 patients | Mean | Standard Deviation | cm |
|
| BMI | Data missing for 3 patients | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
|
| 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. | mITT | Posted | Count of Participants | Participants | At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) |
|
|
|
| 0 |
| 78 |
| 3 |
| 78 |
| 0 |
| 78 |
| EG001 | 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. | 0 | 81 | 0 | 81 | 1 | 81 |
| NECROSIS DUE TO VASCULAR PROBLEM | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| WORSENING OF THE WOUND | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
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