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Completed

NCT Number: NCT01546272

Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.

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Key information

Conditions

ENT Surgery Gynecological Surgery Plastic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Nantes, Nantes, Pays de la Loire Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insorb resorbable staples

Device

Subcutanous suture using resorbable staples

Other names: Insorb staples

Monocryl resorbable wire

Device

Subcutanous suture using resorbable wire

Other names: Monocryl Wire

Primary outcomes

  1. Overall PSAS score measured 3 months after the surgery

    Time frame: 3 months after the surgery

    Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")

Secondary outcomes

  1. Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)

    Time frame: Day 0 (Procedure)

  2. Presence of scarring complications at day 8 (infection, dehiscence)

    Time frame: Day 8

  3. Measurement of suture, surgical and anesthetic times

    Time frame: Day 0 (procedure)

  4. Overall score of the PSAS scale

    Time frame: Months 3, 12 and 18

    The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)

  5. Overall score of the OSAS scale

    Time frame: Months 3, 12 and 18

    The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)

  6. Aesthetic quality of the scar

    Time frame: Month 18

    The aesthetic quality of the scar will be assessed by the patient and a physician (not the surgeon) by a score range from 0 to 10

  7. Quantification of accidental exposure to blood

    Time frame: During the surgery

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: S2CARA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 7, 2012
Registry last updated
Mar 8, 2016

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.

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