Abdominoplasty Clinical Trial
Official title:
Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty
A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
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.
Objective: To study the safety and the preliminary efficacy of a TissuGlu®, a novel surgical
adhesive, in the management of wound drainage during abdominoplasty procedures.
Material & Methods: A blinded prospective randomized trial compared drain fluid output
(volume) and complication profile in 40 subjects undergoing abdominoplasty with (n=20) or
without (n=20) the use of a urethane based adhesive. The TissuGlu® adhesive, which required
no mixing or preparation, was administered to the abdominal wall using a custom drop tip
applicator prior to closure of the abdominoplasty flap. Two Blake® drains connected to J-VAC
suction reservoirs were placed in the wound.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| 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| Withdrawn |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 |