Trial Outcomes & Findings for Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras (NCT NCT02104180)
NCT ID: NCT02104180
Last Updated: 2022-03-21
Results Overview
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Results posted on
2022-03-21
Participant Flow
Participant milestones
| Measure |
TulleGras MS - Urgotul
Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
|
Urgotul - TulleGras MS
Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
TulleGras MS - Urgotul
Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
|
Urgotul - TulleGras MS
Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Baseline characteristics by cohort
| Measure |
TulleGras MS - Urgotul
n=31 Participants
Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
|
Urgotul - TulleGras M.S.
n=31 Participants
Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.3 years
STANDARD_DEVIATION 10.5 • n=93 Participants
|
77.5 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
77.9 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
31 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)Population: Per protocol
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Outcome measures
| Measure |
TulleGras M.S.
n=61 Participants
TulleGras M.S.: Sterile dressing that consists of viscose tissue coated with mineral vaseline
|
Urgotul
n=61 Participants
Urgotul: sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
|
|---|---|---|
|
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
|
11.9 units on a scale: 0-100 mm
Standard Deviation 15.6
|
11.7 units on a scale: 0-100 mm
Standard Deviation 16.7
|
Adverse Events
TulleGras MS - Urgotul
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Urgotul - TulleGras MS
Serious events: 7 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
TulleGras MS - Urgotul
n=31 participants at risk
Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
|
Urgotul - TulleGras MS
n=31 participants at risk
Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
FLARE OF POLYARTHRITIS RHEUMATICA ACUTA
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Skin and subcutaneous tissue disorders
VENOUS ULCERATION
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Investigations
INTERNATIONAL NORMALIZED RATIO ABNORMAL
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Skin and subcutaneous tissue disorders
BASOCELLULAR CARCINOMA
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Vascular disorders
PERIPHERAL VASCULAR DISEASE
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Skin and subcutaneous tissue disorders
AGGRAVATION OF SKIN ULCER
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
General disorders
DEATH BY CANCER AGGRAVATION
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
Other adverse events
| Measure |
TulleGras MS - Urgotul
n=31 participants at risk
Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
|
Urgotul - TulleGras MS
n=31 participants at risk
Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
VENOUS ULCERATION
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
6.5%
2/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Musculoskeletal and connective tissue disorders
LEG PAIN
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Musculoskeletal and connective tissue disorders
TORTICOLLIS
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POPLITEAL CYST
|
3.2%
1/31 • AE collection during the whole study + 30 days following last Patient visit
|
0.00%
0/31 • AE collection during the whole study + 30 days following last Patient visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place