Completed

A Clinical Investigation for a Randomized Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques Plus TissuGlu® and No Drains (Test) During Abdominoplasty

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

TissuGlu Surgical Adhesive

Device
Who is being recruted

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCohera Medical, Inc.
Last updated: December 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The Cohera TissuGlu® study is a pivotal, prospective clinical investigation for a randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques plus TissuGlu® and no drains (test) during abdominoplasty. TissuGlu® will be applied to the test group prior to standard closure of the abdominal flap thereby eliminating the deadspace between the fascia and the flap. No closed suction drains will be inserted in the test group. The control group will receive closed suction drains per the standard of care. It is hypothesized that the elimination of deadspace in the wound in the test group will prevent post-surgical fluid from developing and causing seroma and that the number of invasive treatments related to aspirations in the test group will not be inferior to the management and removal of drains and aspirations for seroma in the control group. The study will be conducted with 130 patients (65 test, 65 control) at up to 5 sites.

NCT01791504
Principal SponsorCohera Medical, Inc.
Last updated: December 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
<= ASA2 - American Society of Anesthesiologists Physical Classification System (2=subject with mild systemic disease)
Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in the study is complete
Have a Body Mass Index (BMI) <= 28
In good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications
Show More Criteria
20 exclusion criteria prevent from participating
Any condition known to effect wound healing, such as collagen vascular disease
Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test
Be known to have a blood clotting disorder and/or be willing to discontinue anti-coagulation therapy including aspirin
Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Standard wound closure techniques plus TissuGlu and no drains.

Group II

No Intervention
Standard wound closure techniques with drains.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa

Huntersville, United StatesOpen The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa in Google Maps
CompletedOne Study Center