ENT SurgeryPhase 3S2CARANCT01546272
Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
A Phase 3 study testing Insorb resorbable staples and Monocryl resorbable wire in people with ENT Surgery and Gynecological Surgery, run by Nantes University Hospital at 24 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ENT Surgery, Gynecological Surgery, Plastic Surgery
- What is being tested?
- Insorb resorbable staples and Monocryl resorbable wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 24 sitesFrance
- Study dates
- Mar 2012to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 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
Who cannot join
- 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
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- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Amiens University Hospital
Amiens
Angers University Hospital
Angers
Besançon University Hospital
Besançon
Bordeaux University Hospital "Centre FX. Michelet"
Bordeaux
Brest University Hospital "Hôpital du Morvan"
Brest
Caen University Hospital "Hôpital de la Côte de Nacre"
Caen
Lille University Hospital "Hôpital Roger Salengro"
Lille
"Assistance Publique des Hôpitaux de Marseille - La Conception"
Marseille
Montpellier University Hospital "Hôpital Gui de Chauliac"
Montpellier
Mulhouse Hospital "Emile Muller"
Mulhouse
CHU de Nantes
Nantes, Pays de la Loire Region, 44000
CHU Nantes
Nantes
"Institut de Cancérologie de Nice"
Nice
"Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"
Paris
CHU Poitiers
Poitiers
Poitiers University Hospital
Poitiers
Rennes University Hospital "CHU Pontchaillou"
Rennes
Rennes University Hospital
Rennes
Rouen University Hospital
Rouen
Strasbourg University Hospital "Hôpital Hautepierre"
Strasbourg
"Institut Claudius Regaud"
Toulouse
"Pôle Santé Léonard de Vinci"
Tours
Pôle Santé Léonard de Vinci
Tours
Tours University Hospital
Tours
About this study
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.
- Conditions
- ENT Surgery, Gynecological Surgery, Plastic Surgery
- Being tested
- Insorb resorbable staples, Monocryl resorbable wire
- Keywords
- Subcutaneous resorbable sutures, Tolerance / effectiveness of subcutaneous suture, Reduced operative time and anesthesia time, Medico-economic evaluation, Accidental exposure to blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insorb resorbable staplesDevice
Also called Insorb staples
Subcutanous suture using resorbable staples
Monocryl resorbable wireDevice
Also called Monocryl Wire
Subcutanous suture using resorbable wire
| Study group | Role | What they receive |
|---|---|---|
| Resorbable staples | Experimental | Suture using Insorb Resorbable staples Receives: Device: Insorb resorbable staples |
| Resorbable wires | Active comparator | Suture using Monocryl resorbable wire Receives: Device: Monocryl resorbable wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall PSAS score measured 3 months after the surgery
Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")
Measured: 3 months after the surgery
Secondary outcomes (7)
Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
Measured: Day 0 (Procedure)
Presence of scarring complications at day 8 (infection, dehiscence)
Measured: Day 8
Measurement of suture, surgical and anesthetic times
Measured: Day 0 (procedure)
Overall score of the PSAS scale
The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)
Measured: Months 3, 12 and 18
Overall score of the OSAS scale
The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)
Measured: Months 3, 12 and 18
Aesthetic quality of the scar
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
Measured: Month 18
Quantification of accidental exposure to blood
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Malard, Professor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546272
- Sponsor's protocol ID
- RC11_0147
- Acronym
- S2CARA
- Status last verified
- Mar 2016
- First submitted
- 21 Feb 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
- ClinicalTrials.gov ID
- NCT01546272
- Acronym / sponsor ID
- S2CARA / RC11_0147
- Conditions
- ENT Surgery, Gynecological Surgery, Plastic Surgery
- Keywords
- Subcutaneous resorbable sutures, Tolerance / effectiveness of subcutaneous suture, Reduced operative time and anesthesia time, Medico-economic evaluation, Accidental exposure to blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resorbable staples | Experimental | Device: Insorb resorbable staplesSuture using Insorb Resorbable staples |
| Resorbable wires | Active comparator | Device: Monocryl resorbable wireSuture using Monocryl resorbable wire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Insorb resorbable staplesAlso: Insorb staplesSubcutanous suture using resorbable staples | Device | Resorbable staples |
| Monocryl resorbable wireAlso: Monocryl WireSubcutanous suture using resorbable wire | Device | Resorbable wires |
Primary outcome
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")
7 secondary outcomes
Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
Time frame: Day 0 (Procedure)
Presence of scarring complications at day 8 (infection, dehiscence)
Time frame: Day 8
Measurement of suture, surgical and anesthetic times
Time frame: Day 0 (procedure)
Overall score of the PSAS scale
Time frame: Months 3, 12 and 18
Overall score of the OSAS scale
Time frame: Months 3, 12 and 18
Aesthetic quality of the scar
Time frame: Month 18
Quantification of accidental exposure to blood
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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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.
Olivier Malard, Professor principal investigator
Nantes University Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insorb resorbable staples and Monocryl resorbable wire in people with ENT Surgery and Gynecological Surgery, run by Nantes University Hospital at 24 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 6 inclusion and 10 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall PSAS score measured 3 months after the surgery (time frame: 3 months after the surgery). 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 8 Mar 2016.