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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT01546272 |
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Date of registration:
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21/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
S2CARA |
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Scientific title:
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Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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664 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01546272 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Olivier Malard, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nantes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female aged 18 yrs to 75 yrs
- Patient supported for a scheduled surgery :
For abdominoplasty, cervicotomy or suprapubic surgery With a open incision necessary for
operative exposition of 10 cm or more with a straight or curved surgery incision
- Person covered by Health Insurance
- ECOG Performance Status 0 or 1
- Patient's informed and written consent
Exclusion Criteria:
- Incision imposing a very angular or sinuous scar for which the use of the medical
device is deemed unsuited (sinuous or bayonet incisions)
- Known history of intolerance to any component of the medical device
- Immunocompromised patients or undergoing a long term treatment by corticosteroids or
immunosuppressants
- Known or anticipated presence of a skin infection (due to the infected skin
condition, or because of underlying surgery conducted in infected territory or likely
to be)
- Dermatological disease or skin treatment in progress
- History of radiation therapy on the surgical site or antimitotic treatment in
progress
- Pregnancy at the time of suture
- Patients simultaneously included in another treatment protocol
- Patients under legal guardianship
- Non French speaking patients, refusing or unfit for the monitoring proposed in the
study
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ENT Surgery
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Gynecological Surgery
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Plastic Surgery
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Intervention(s)
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Device: Monocryl resorbable wire
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Device: Insorb resorbable staples
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Primary Outcome(s)
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Overall PSAS score measured 3 months after the surgery
[Time Frame: 3 months after the surgery]
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Secondary Outcome(s)
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Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
[Time Frame: Day 0 (Procedure)]
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Measurement of suture, surgical and anesthetic times
[Time Frame: Day 0 (procedure)]
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Overall score of the PSAS scale
[Time Frame: Months 3, 12 and 18]
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Overall score of the OSAS scale
[Time Frame: Months 3, 12 and 18]
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Presence of scarring complications at day 8 (infection, dehiscence)
[Time Frame: Day 8]
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Quantification of accidental exposure to blood
[Time Frame: During the surgery]
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Aesthetic quality of the scar
[Time Frame: Month 18]
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Secondary ID(s)
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RC11_0147
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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