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Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

NCT01546272 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2016-03-08

No results posted yet for this study

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

Interventions

DEVICE

Insorb resorbable staples

Subcutanous suture using resorbable staples

DEVICE

Monocryl resorbable wire

Subcutanous suture using resorbable wire

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Olivier Malard, Professor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-05-31
Completion
2015-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546272 on ClinicalTrials.gov