An interventional study of Lomatuell Pro and UrgoTul in Acute Wounds, sponsored by Lohmann & Rauscher. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by Lohmann & Rauscher · Not applicable, Interventional, and Treatment
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.
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Lomatuell Pro
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.
Device: UrgoTul
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.
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.
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)
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)
First patient enrolled on 11 February 2019. Last patient enrolled on 16 November 2020.
| Milestone | Lomatuell Pro | UrgoTul |
|---|---|---|
| Started | 78 | 81 |
| Completed | 71 | 79 |
| Not completed | 7 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Complete healing by v2 | 1 | 0 |
| Withdrew: Occurence of exclusion criterion | 1 | 1 |
| Withdrew: Other | 1 | 0 |
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).
| percentage of dressing changes | Lomatuell Pro | UrgoTul |
|---|---|---|
| Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) | 97.4 (97.01 to 98.06) | 97.5 (97.12 to 98.16) |
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.
| Participants | Lomatuell Pro | UrgoTul |
|---|---|---|
| Complete Healing | 48 | 55 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lomatuell Pro | 0/78 (0%) | 3/78 (3.8%) | 0/78 (0%) |
| UrgoTul | 0/81 (0%) | 0/81 (0%) | 1/81 (1.2%) |
| Event | Lomatuell Pro | UrgoTul |
|---|---|---|
| INFLAMED DIABETIC FOOT ULCERSkin and subcutaneous tissue disorders | 1/78 | 0/81 |
| NECROSIS DUE TO VASCULAR PROBLEMSkin and subcutaneous tissue disorders | 1/78 | 0/81 |
| WORSENING OF THE WOUNDSkin and subcutaneous tissue disorders | 1/78 | 0/81 |
| Event | Lomatuell Pro | UrgoTul |
|---|---|---|
| Wound infectionSkin and subcutaneous tissue disorders | 0/78 | 1/81 |
| Age, Continuous(years) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Mean | 73.83 ± 22.775 | 71.28 ± 22.364 | 72.53 ± 22.530 |
| Sex: Female, Male(Participants) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Female | 43 | 40 | 83 |
| Male | 35 | 41 | 76 |
| Race and Ethnicity Not Collected(Participants) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| France | 78 | 81 | 159 |
| Weight(kg) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Mean | 67.85 ± 15.821 | 71.85 ± 14.362 | 69.86 ± 15.189 |
| Height(cm) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Mean | 165.97 ± 10.198 | 167.82 ± 9.065 | 166.9 ± 9.658 |
| BMI(kg/m^2) | Lomatuell Pro | UrgoTul | Total |
|---|---|---|---|
| Mean | 24.5 ± 5.07 | 25.5 ± 5.30 | 25.0 ± 5.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2019 to primary completion in Dec 2020, 21 months.
Results were first posted in Feb 2025, 4 years 2 months after primary completion.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Lohmann & Rauscher