Trial Outcomes & Findings for Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds (NCT NCT03897465)
NCT ID: NCT03897465
Last Updated: 2025-10-29
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
At Visit 2 (Day 3 ± 2 days)
Results posted on
2025-10-29
Participant Flow
First patient enrolled on 11 February 2019. Last patient enrolled on 16 November 2020.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
81
|
|
Overall Study
COMPLETED
|
71
|
79
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
complete healing by V2
|
1
|
0
|
|
Overall Study
occurence of exclusion criterion
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lomatuell Pro
n=78 Participants
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.
|
UrgoTul
n=81 Participants
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.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.83 years
STANDARD_DEVIATION 22.775 • n=78 Participants
|
71.28 years
STANDARD_DEVIATION 22.364 • n=81 Participants
|
72.53 years
STANDARD_DEVIATION 22.530 • n=159 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=78 Participants
|
40 Participants
n=81 Participants
|
83 Participants
n=159 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=78 Participants
|
41 Participants
n=81 Participants
|
76 Participants
n=159 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
78 participants
n=78 Participants
|
81 participants
n=81 Participants
|
159 participants
n=159 Participants
|
|
Weight
|
67.85 kg
STANDARD_DEVIATION 15.821 • n=78 Participants • Data missing for 2 patients
|
71.85 kg
STANDARD_DEVIATION 14.362 • n=79 Participants • Data missing for 2 patients
|
69.86 kg
STANDARD_DEVIATION 15.189 • n=157 Participants • Data missing for 2 patients
|
|
Height
|
165.97 cm
STANDARD_DEVIATION 10.198 • n=78 Participants • Data missing for 2 patients
|
167.82 cm
STANDARD_DEVIATION 9.065 • n=79 Participants • Data missing for 2 patients
|
166.9 cm
STANDARD_DEVIATION 9.658 • n=157 Participants • Data missing for 2 patients
|
|
BMI
|
24.5 kg/m^2
STANDARD_DEVIATION 5.07 • n=78 Participants • Data missing for 3 patients
|
25.5 kg/m^2
STANDARD_DEVIATION 5.30 • n=78 Participants • Data missing for 3 patients
|
25.0 kg/m^2
STANDARD_DEVIATION 5.2 • n=156 Participants • Data missing for 3 patients
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Lomatuell Pro
n=77 Participants
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.
|
UrgoTul
n=81 Participants
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.
|
|---|---|---|
|
Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)
|
97.4 percentage of dressing changes
Interval 97.01 to 98.06
|
97.5 percentage of dressing changes
Interval 97.12 to 98.16
|
SECONDARY outcome
Timeframe: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)Population: mITT
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.
Outcome measures
| Measure |
Lomatuell Pro
n=78 Participants
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.
|
UrgoTul
n=81 Participants
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.
|
|---|---|---|
|
Complete Healing
|
48 Participants
|
55 Participants
|
Adverse Events
Lomatuell Pro
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
UrgoTul
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lomatuell Pro
n=78 participants at risk
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.
|
UrgoTul
n=81 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
INFLAMED DIABETIC FOOT ULCER
|
1.3%
1/78 • Number of events 1 • 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.
|
0.00%
0/81 • 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.
|
|
Skin and subcutaneous tissue disorders
NECROSIS DUE TO VASCULAR PROBLEM
|
1.3%
1/78 • Number of events 1 • 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.
|
0.00%
0/81 • 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.
|
|
Skin and subcutaneous tissue disorders
WORSENING OF THE WOUND
|
1.3%
1/78 • Number of events 1 • 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.
|
0.00%
0/81 • 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.
|
Other adverse events
| Measure |
Lomatuell Pro
n=78 participants at risk
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.
|
UrgoTul
n=81 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Wound infection
|
0.00%
0/78 • 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.
|
1.2%
1/81 • Number of events 1 • 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.
|
Additional Information
Dr Daria Trofimenko, Senior Manager Clinical Regulatory Affairs
Lohmann & Rauscher GmbH & Co. KG
Phone: +49 (0) 2631 99 6385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place