Surgical Acute WoundsNCT02322710
Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
A study testing Urgotul: Low-adherent dressing and TulleGras M.S.: Vaseline gauze in people with Surgical Acute Wounds, run by Mylan Inc. at 33 sites in France.
Trial summary
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Acute Wounds
- What is being tested?
- Urgotul: Low-adherent dressing and TulleGras M.S.: Vaseline gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 33 sitesFrance
- Study dates
- Dec 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Followed-up in surgery department
- Written and signed informed consent obtained
- Affiliated to the French Social Security system or equivalent.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Research facility ID ORG-001264
Ajaccio, 20303
Research facility ID ORG-001263
Angoulême, 16959
Research facility ORG-001090
Athis-Mons, 91200
Research facility ORG-001101
Aubervilliers, 93300
Research facility ID ORG-001099
Carpentras, 84200
Research facility ORG-001099
Carpentras, 84200
Research facility ORG-001107
Cornebarrieu, 31700
Research facility ID ORG-001223
La Rochelle, 17000
Research facility ORG-001096
Levallois-Perret, 92300
Research facility ID ORG-001276
Lille, 59037
Research facility ORG-001102
Lille, 59037
Research facility ORG-001360
Lyon, 69003
Research facility ORG-001132
Mantes-la-Jolie, 78200
Research facility ID ORG-001133
Montpellier, 34295
Research facility ORG-001133
Montpellier, 34295
Research facility ID ORG-001220
Montreuil, 93105
Research facility ID ORG-001189
Nice, 6002
Research facility ID ORG-001190
Ollioules, 89190
Research facility ID ORG-001088
Paris, 75008
Research facility ID ORG-001105
Paris, 75008
Research facility ORG-001105
Paris, 75008
Research facility ID ORG-001134
Paris, 75014
Research facility ID ORG-001265
Paris, 75014
Research facility ORG-001088
Paris, 75018
Research facility ID ORG-001221
Paris, 75877
Research facility ORG-001166
Pierre-Bénite, 69495
Research facility ID ORG-001278
Reims, 51090
Research facility ORG-001137
Roubaix, 59100
Research facility ORG-001136
Rouen, 76000
Research facility ORG-001089
Saint-Nazaire, 44600
Research facility ID ORG-001222
Sarreguemines, 57200
Research facility ORG-001097
Sarreguemines, 57200
Research facility ORG-001093
Toulon, 83100
About this study
Official 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.
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
- Conditions
- Surgical Acute Wounds
- Being tested
- Urgotul: Low-adherent dressing, TulleGras M.S.: Vaseline gauze
- Keywords
- non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgotul: Low-adherent dressingDevice
TulleGras M.S.: Vaseline gauzeDevice
| Study group | Role | What they receive |
|---|---|---|
| TulleGras M.S. | Active comparator | Sterile dressing that consists of viscose tissue coated with mineral vaseline Receives: Device: TulleGras M.S.: Vaseline gauze |
| Urgotul | Active comparator | Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline Receives: Device: Urgotul: Low-adherent dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete Healing (100% of Epithelialization).
Using photographs,independent assessor blinded assessment.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Acute WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fovea
- Responsible party
- Sponsor
- Investigators
- Roger LESAUNIER, MD, Study director, Mylan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322710
- Sponsor's protocol ID
- LINE4002
- Other IDs
- 2014-A00914-43
- Status last verified
- Mar 2017
- First submitted
- 19 Dec 2014
- Last updated
- 21 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02322710
- Acronym / sponsor ID
- LINE4002
- Conditions
- Surgical Acute Wounds
- Keywords
- non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fovea
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TulleGras M.S. | Active comparator | Device: TulleGras M.S.: Vaseline gauzeSterile dressing that consists of viscose tissue coated with mineral vaseline |
| Urgotul | Active comparator | Device: Urgotul: Low-adherent dressingSterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urgotul: Low-adherent dressing | Device | Urgotul |
| TulleGras M.S.: Vaseline gauze | Device | TulleGras M.S. |
Primary outcome
Percentage of Patients With Complete Healing (100% of Epithelialization).
Time frame: Day 21
Using photographs,independent assessor blinded assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Surgical Acute Wounds
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Recruiting
Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery
Orthopaedic Fractures, Orthopaedic Trauma Fractures and Non-unions
Not yet recruitingObservational study
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury
Recruiting
Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Surgeries Undergoing General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger LESAUNIER, MD study director
Mylan
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgotul: Low-adherent dressing and TulleGras M.S.: Vaseline gauze in people with Surgical Acute Wounds, run by Mylan Inc. at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Complete Healing (100% of Epithelialization). (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.