Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

NCT01546272 | Completed Phase 3

• 1 other identifier: RC11_0147
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 24

Brief 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 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

Keywords

Subcutaneous resorbable sutures; Tolerance / effectiveness of subcutaneous suture; Reduced operative time and anesthesia time; Medico-economic evaluation; Accidental exposure to blood

Outcome Measures

Primary Outcomes (1)

• Overall PSAS score measured 3 months after the surgery

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

  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)

  Day 0 (Procedure)

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

  Day 8

• Measurement of suture, surgical and anesthetic times

  Day 0 (procedure)

• Overall score of the PSAS scale

  Months 3, 12 and 18

• Overall score of the OSAS scale

  Months 3, 12 and 18

Study Arms (2)

Resorbable staples

EXPERIMENTAL

Suture using Insorb Resorbable staples

Device: Insorb resorbable staples

Resorbable wires

ACTIVE COMPARATOR

Suture using Monocryl resorbable wire

Device: Monocryl resorbable wire

Interventions

Insorb resorbable staples DEVICE

Subcutanous suture using resorbable staples

Also known as: Insorb staples

Resorbable staples

Monocryl resorbable wire DEVICE

Subcutanous suture using resorbable wire

Also known as: Monocryl Wire

Resorbable wires

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (24)

CHU de Nantes

Nantes, Pays de la Loire Region, 44000, France

Location

Amiens University Hospital

Amiens, France

Location

Angers University Hospital

Angers, France

Location

Besançon University Hospital

Besançon, France

Location

Bordeaux University Hospital "Centre FX. Michelet"

Bordeaux, France

Location

Brest University Hospital "Hôpital du Morvan"

Brest, France

Location

Caen University Hospital "Hôpital de la Côte de Nacre"

Caen, France

Location

Lille University Hospital "Hôpital Roger Salengro"

Lille, France

Location

"Assistance Publique des Hôpitaux de Marseille - La Conception"

Marseille, France

Location

Montpellier University Hospital "Hôpital Gui de Chauliac"

Montpellier, France

Location

Mulhouse Hospital "Emile Muller"

Mulhouse, France

Location

CHU Nantes

Nantes, France

Location

"Institut de Cancérologie de Nice"

Nice, France

Location

"Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Poitiers University Hospital

Poitiers, France

Location

Rennes University Hospital "CHU Pontchaillou"

Rennes, France

Location

Rennes University Hospital

Rennes, France

Location

Rouen University Hospital

Rouen, France

Location

Strasbourg University Hospital "Hôpital Hautepierre"

Strasbourg, France

Location

"Institut Claudius Regaud"

Toulouse, France

Location

"Pôle Santé Léonard de Vinci"

Tours, France

Location

Pôle Santé Léonard de Vinci

Tours, France

Location

Tours University Hospital

Tours, France

Location

Study Officials

• Olivier Malard, Professor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

FR (24)