Trial Outcomes & Findings for Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds. (NCT NCT02322710)
NCT ID: NCT02322710
Last Updated: 2022-03-21
Results Overview
Using photographs,independent assessor blinded assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
Day 21
Results posted on
2022-03-21
Participant Flow
4 patients were not randomized Presence of clinical sign suggestive of worsened wound assessed at the randomization visit (n=4)
Participant milestones
| Measure |
TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
99
|
|
Overall Study
Safety Population
|
105
|
99
|
|
Overall Study
Full Analysis Population
|
105
|
98
|
|
Overall Study
COMPLETED
|
85
|
73
|
|
Overall Study
NOT COMPLETED
|
20
|
26
|
Reasons for withdrawal
| Measure |
TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
|---|---|---|
|
Overall Study
No efficacy assessment post-baseline
|
0
|
1
|
|
Overall Study
Protocol Violation
|
20
|
25
|
Baseline Characteristics
Full analysis population = 203
Baseline characteristics by cohort
| Measure |
TulleGras M.S.
n=105 Participants
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
n=98 Participants
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 13.2 • n=105 Participants • Full analysis population = 203
|
54.4 years
STANDARD_DEVIATION 14.1 • n=98 Participants • Full analysis population = 203
|
53.4 years
STANDARD_DEVIATION 13.6 • n=203 Participants • Full analysis population = 203
|
|
Sex: Female, Male
Female
|
39 Participants
n=105 Participants • Full analysis population = 203
|
43 Participants
n=98 Participants • Full analysis population = 203
|
82 Participants
n=203 Participants • Full analysis population = 203
|
|
Sex: Female, Male
Male
|
66 Participants
n=105 Participants • Full analysis population = 203
|
55 Participants
n=98 Participants • Full analysis population = 203
|
121 Participants
n=203 Participants • Full analysis population = 203
|
|
Weight
|
85.4 Kg
STANDARD_DEVIATION 21.6 • n=99 Participants • Full analysis population = 203 Missing data = 10
|
83.0 Kg
STANDARD_DEVIATION 18.9 • n=94 Participants • Full analysis population = 203 Missing data = 10
|
84.2 Kg
STANDARD_DEVIATION 20.3 • n=193 Participants • Full analysis population = 203 Missing data = 10
|
|
Height
|
170.4 Cm
STANDARD_DEVIATION 9.6 • n=99 Participants • Full analysis population = 203 Missing data = 10
|
170.0 Cm
STANDARD_DEVIATION 9.2 • n=94 Participants • Full analysis population = 203 Missing data = 10
|
170.2 Cm
STANDARD_DEVIATION 9.4 • n=193 Participants • Full analysis population = 203 Missing data = 10
|
|
Body Mass Index
|
29.6 kg/m²
STANDARD_DEVIATION 8.3 • n=99 Participants • Full analysis population = 10 Missing data = 10
|
28.9 kg/m²
STANDARD_DEVIATION 7.2 • n=94 Participants • Full analysis population = 10 Missing data = 10
|
29.2 kg/m²
STANDARD_DEVIATION 7.8 • n=193 Participants • Full analysis population = 10 Missing data = 10
|
PRIMARY outcome
Timeframe: Day 21Population: Per protocol population
Using photographs,independent assessor blinded assessment.
Outcome measures
| Measure |
TulleGras M.S.
n=85 Participants
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
n=73 Participants
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
|---|---|---|
|
Percentage of Patients With Complete Healing (100% of Epithelialization).
|
77 Participants
|
67 Participants
|
Adverse Events
TulleGras M.S.
Serious events: 14 serious events
Other events: 23 other events
Deaths: 0 deaths
Urgotul
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TulleGras M.S.
n=105 participants at risk
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
n=99 participants at risk
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.95%
1/105
|
0.00%
0/99
|
|
Gastrointestinal disorders
gastric fistula
|
0.95%
1/105
|
0.00%
0/99
|
|
Infections and infestations
eschereschia coli
|
0.95%
1/105
|
1.0%
1/99
|
|
Infections and infestations
pyelonephretis
|
0.00%
0/105
|
2.0%
2/99
|
|
General disorders
hyperthermia
|
0.95%
1/105
|
1.0%
1/99
|
|
Injury, poisoning and procedural complications
post procédural constipation
|
0.95%
1/105
|
0.00%
0/99
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.95%
1/105
|
0.00%
0/99
|
|
Vascular disorders
haemorroids thrombosed
|
0.95%
1/105
|
0.00%
0/99
|
|
Blood and lymphatic system disorders
anaemia
|
1.9%
2/105
|
0.00%
0/99
|
|
Renal and urinary disorders
urinary retention
|
0.95%
1/105
|
1.0%
1/99
|
|
Investigations
hypokaliaemia
|
0.95%
1/105
|
0.00%
0/99
|
|
Blood and lymphatic system disorders
lymphopenia
|
0.95%
1/105
|
0.00%
0/99
|
|
Gastrointestinal disorders
ileus
|
0.00%
0/105
|
1.0%
1/99
|
|
Vascular disorders
hypertension
|
0.00%
0/105
|
1.0%
1/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate sarcoma
|
0.95%
1/105
|
0.00%
0/99
|
|
Hepatobiliary disorders
asymptomatic cholostasis
|
0.95%
1/105
|
0.00%
0/99
|
Other adverse events
| Measure |
TulleGras M.S.
n=105 participants at risk
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
|
Urgotul
n=99 participants at risk
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
|
|---|---|---|
|
Injury, poisoning and procedural complications
procedural pain
|
8.6%
9/105
|
13.1%
13/99
|
|
Gastrointestinal disorders
abdominal pain
|
9.5%
10/105
|
2.0%
2/99
|
|
Gastrointestinal disorders
nausea
|
0.95%
1/105
|
9.1%
9/99
|
|
General disorders
pain
|
2.9%
3/105
|
6.1%
6/99
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place