Clinical trial NCT01162564: Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
Official title: Single-Arm, Prospective, Multi-Center Observational Study of a Flexible Composite Next Generation Tissue Separating Mesh(NG-TSM)to Assess Ease of Use and Early Outcomes in Laparoscopic Incisional/Ventral Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Ventral Hernia
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result

Brief summary: This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and handling characteristics.

Detailed description: The objectives of the study are to evaluate the ease of use of NG-TSM intra-operatively in laparoscopic incisional/ventral hernia repair, and assessing early outcomes post-operatively following mesh implantation, including seroma formation, hematoma, wound complications, infections, early recurrences, adverse events, and subject comfort, as well as health economic data to include quality of life, subject satisfaction data, time of procedure, length of stay, re-hospitalization, and extended hospitalization.

Eligibility criteria: Inclusion Criteria:

* Subject must be able to provide written informed consent
* Male or female subjects that are ≥ 18 years of age
* Female subjects must be using adequate contraception, or be surgically sterile, postmenopausal or practicing abstinence, and not planning to become pregnant
* Planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result

Exclusion Criteria:

* Subjects with a potential growth as NGTSM will not stretch significantly
* Female subjects who are pregnant on the day of implantation
* Surgical site (mesh implantation site) that is classified as contaminated (acute, non purulent, inflamed) or dirty/infected (containing retained devitalized tissue and those that involve existing clinical infection or perforated viscera)
* Subjects who have received investigational articles less than 30 days prior to enrollment or who are currently receiving investigational products or devices
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jefferson City
country: United States
facility: Capital Region Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine / Dept of Surgery
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Pinehurst
country: United States
facility: First Health Moore Regional Hospital
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Hospital
state: North Carolina
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Ethicon, Inc.
name: Lynn McRoy, MD
role: STUDY_DIRECTOR
References: