Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty

NCT01331798 | Completed Phase 1 DMC

• 1 other identifier: PRO-100-0002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Abdominoplasty

Keywords

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• • Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device and non-device related adverse events occurring among study subjects.

  Discharge, 14, 30, 60, 90 Day follow-up

Secondary Outcomes (6)

• • Time to drain removal based upon a drain removal criteria of <30ml of fluid accumulation in a twenty four (24) hour period (Scevola et al, 2002; Momeni et al, 2008).

  Assessed at time of drain removal- Average 2 to 5 days post surgery.

• • Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma

  Discharge, 14, 30, 60, 90 Day follow-up

• • Cumulative drainage volume for each patient

  Assessed at time of drain removal- Average 2-5 days post surgery.

• • Number of additional physician or clinic visits

  Discharge, 14, 30, 60, 90 Day follow-up

• • Number/type of additional procedures due to complications

  Discharge, 14, 30, 60, 90 Day follow-up

Study Arms (2)

Test: TissuGlu Adhesive

EXPERIMENTAL

Patients received the TissuGlu Adhesive Treatment

Device: Cohera TissuGlu Surgical Adhesive

Control

ACTIVE COMPARATOR

Control Arm received no TissuGlu- Standard of Care received.

Procedure: Control- Standard of care

Interventions

Cohera TissuGlu Surgical Adhesive DEVICE

TissuGlu device used prior to closing of the flap in the abdominoplasty procedure.

Test: TissuGlu Adhesive

Control- Standard of care PROCEDURE

Control Arm- no TissuGlu device used. Standard abdominoplasty procedure followed.

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 20 years of age;
• Be 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;
• Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure, Surgeon must use electrocautery in the procedure;
• Be willing to follow instructions for incision care, comply with schedule for wound drainage volume measurements, and follow guidelines related to resumption of daily activities;
• Agree to return for all follow-up evaluations specified in this protocol;
• Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete; and
• Sign the informed consent.

You may not qualify if:

• Anesthesia Risk judged to be higher than ASA2
• Previous Abdominoplasty
• Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
• Any condition involving compromised vascular flow to the abdominal wall tissue. Prior abdominal scars, especially subcostal scars, will be a relative contraindication and judged on a case by case basis by the surgeon investigator.
• Any condition known to effect wound healing, such as collagen vascular disease
• Current active tobacco use, including smokeless (chewing) tobacco
• Obesity, as defined by BMI \>30
• Known blood clotting disorder
• Current diagnosis of diabetes
• Be receiving antibiotic therapy for pre-existing condition or infection
• Have known personal or family history of keloid formation or hypertrophy
• Undergoing concurrent adjacent or congruent Liposuction procedures
• Concurrent use of fibrin sealants or other internal wound care devices
• Be currently taking systemic steroids or immunosuppressive agents
• Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Sites (3)

University of Bonn

Bonn, Germany

Location

Rosenpark Klinik

Darmstadt, Germany

Location

Erich-Lexer-Klinik

Freiburg im Breisgau, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 8, 2011
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 8, 2011

Record last verified: 2011-04

Locations

DE (3)