Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Phase 3

Completed

• Conditions: Plastic Surgery; ENT Surgery; Gynecological Surgery
• Interventions: Device: Monocryl resorbable wire; Device: Insorb resorbable staples

• Registration Number: NCT01546272
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2014-05
• Study Completion: 2015-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resorbable wires	Monocryl resorbable wire	Suture using Monocryl resorbable wire
Resorbable staples	Insorb resorbable staples	Suture using Insorb Resorbable staples

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall score of the OSAS scale	Months 3, 12 and 18	The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)
Aesthetic quality of the scar	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
Quantification of accidental exposure to blood	During the surgery
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	The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)

Trial Locations

Locations (24)

CHU de Nantes; 🇫🇷 Nantes, Pays de la Loire, France

Amiens University Hospital; 🇫🇷 Amiens, France

Besançon University Hospital; 🇫🇷 Besançon, France

Bordeaux University Hospital "Centre FX. Michelet"; 🇫🇷 Bordeaux, France

Caen University Hospital "Hôpital de la Côte de Nacre"; 🇫🇷 Caen, France

Lille University Hospital "Hôpital Roger Salengro"; 🇫🇷 Lille, France

"Assistance Publique des Hôpitaux de Marseille - La Conception"; 🇫🇷 Marseille, France

Montpellier University Hospital "Hôpital Gui de Chauliac"; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France

"Institut de Cancérologie de Nice"; 🇫🇷 Nice, France

"Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

"Institut Claudius Regaud"; 🇫🇷 Toulouse, France

Rouen University Hospital; 🇫🇷 Rouen, France

Rennes University Hospital "CHU Pontchaillou"; 🇫🇷 Rennes, France

Strasbourg University Hospital "Hôpital Hautepierre"; 🇫🇷 Strasbourg, France

Pôle Santé Léonard de Vinci; 🇫🇷 Tours, France

"Pôle Santé Léonard de Vinci"; 🇫🇷 Tours, France

Tours University Hospital; 🇫🇷 Tours, France

Brest University Hospital "Hôpital du Morvan"; 🇫🇷 Brest, France

Mulhouse Hospital "Emile Muller"; 🇫🇷 Mulhouse, France

Rennes University Hospital; 🇫🇷 Rennes, France

Angers University Hospital; 🇫🇷 Angers, France