NCT Number: NCT02322710
Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Research facility ID ORG-001264, Ajaccio, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female subject.
- Aged 18 to 75 years
- With a planned surgery:
- Of abdominal location
- Leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products)
- Absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit)
- Followed-up in surgery department
- Written and signed informed consent obtained
- Affiliated to the French Social Security system or equivalent.
Exclusion criteria
- Underlying pathology that may interfere with wound healing in the opinion of the Investigator (human immunodeficiency virus [HIV], cancer, immunodeficiency disease, generalized infection, systemic disease ...). The presence of low-risk prostate cancer according to the Amico classification (1) (PSA<10 ng/mL and Gleason's score < 6 and clinical grade T1c ou T2a) or a grade T1 (a or b) N0M0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria
- Inadequately controlled diabetes (Glycosylated hemoglobin > 8%)
- Hypo or hyperthyroidism
- Intake of a systemic treatment with glucocorticoids or immunosuppressives
- Known allergy to one of study dressings components
- Participation in a clinical trial in the month prior to his/her inclusion in the study
- Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
Treatment and study plan
TulleGras M.S.: Vaseline gauze
DevicePrimary outcomes
-
Percentage of Patients With Complete Healing (100% of Epithelialization).
Time frame: Day 21
Using photographs,independent assessor blinded assessment.
Sponsors and collaborators
Lead sponsor
Mylan Inc.
Industry
Collaborators
- Fovea
Registry information
Official study title
Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 23, 2014
- Registry last updated
- Mar 21, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsLow vs Medium Pressure Pneumoperitoneum
NCT04949659
Appendicitis, Appendicitis Acute
Zurich, Canton of Zurich, Switzerland
View Trial DetailsPectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement
NCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsPain Neuroscience Education for Middle School Students
NCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial Details