Clinical Trials Logo

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.


Clinical Trial Description

Background:

Fluid accumulation in dissected tissue planes has been a longstanding problem following surgical procedures. The common use of closed suction drains has been associated with infection risk, wound healing complications, additional scarring, and patient discomfort. Additionally, seroma formation after drain removal often requires invasive treatment. Therapies that can reduce fluid accumulation and decrease the need for drains will have a positive impact on surgical practice.

Objectives:

- To establish that the use of TissuGlu® Surgical Adhesive is a safe and effective alternative to drains (standard of care) for fluid management following abdominoplasty.

- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative invasive treatments, and seroma formation.

- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative subject satisfaction and quality of life.

- To document the type and duration of adverse events associated with TissuGlu® used during an abdominoplasty procedure as an alternative to drains.

Material and Methods:

A prospective randomized trial comparing standard wound closure technique with drains in 130 subjects (control group n=65) to standard wound closure techniques plus TissuGlu® and no drains (test group n=65) during Abdominoplasty.

For subjects randomized into the Test Group, TissuGlu® will be applied to one surface of the exposed tissue flap using the custom applicator during a standard abdominoplasty procedure followed by normal wound closure (suturing technique) without drain placement. The applicator device will deliver an array of drops spaced equidistant apart. The user may then reposition the device to the next area and repeat the application process. Each device will dispense approximately 5 ml of adhesive. It is expected that one 5 ml device will suffice for the average sized subject (400-500 sq cm tissue flap). The TissuGlu® is applied using the disposable applicator to the tissue surfaces to be adhered just prior to standard closure. The tissue is then approximated, and the wound is closed using standard suturing techniques. TissuGlu® will begin to cure upon exposure to moisture in the tissue. The cure process takes approximately 30-45 minutes.

Subjects that are randomized to the Control Group will undergo normal wound closure (suturing technique) and placement of two size 12 Blake drains. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01526954
Study type Interventional
Source Cohera Medical, Inc.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2012
Completion date November 2013

See also
  Status Clinical Trial Phase
Completed NCT03143959 - Functional Improvement With Abdominoplasty N/A
Active, not recruiting NCT04207047 - Histologic Evaluation of Tissue Following Lutronic System Exposure N/A
Active, not recruiting NCT04712331 - Effect of Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty N/A
Completed NCT02949778 - Quadratus Lumborum Block for Abdominoplasty Phase 4
Active, not recruiting NCT01026662 - In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue Phase 2/Phase 3
Withdrawn NCT03770195 - Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Terminated NCT03429556 - Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty Phase 2
Terminated NCT02302222 - The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing N/A
Recruiting NCT05939518 - Fluid Therapy and Glycocalyx Shedding During Moderate Surgery N/A
Active, not recruiting NCT05490602 - Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
Completed NCT01389635 - Abdominoplasty Under Epidural Anesthesia N/A
Recruiting NCT04670224 - Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery N/A
Recruiting NCT03190876 - Seroma Prevention After Body Contouring Procedures N/A
Recruiting NCT04787874 - Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures N/A
Completed NCT01604694 - Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty Phase 4
Withdrawn NCT02140385 - Role of Preservation of Scarpa's Fascia in Abdominoplasty N/A
Completed NCT04182880 - Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain Phase 2
Completed NCT03467724 - Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift N/A
Not yet recruiting NCT02930447 - Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty N/A
Enrolling by invitation NCT06043557 - Patient Satisfaction and Reflection on Drain Placement N/A