Status:
COMPLETED
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
Lead Sponsor:
Cohera Medical, Inc.
Conditions:
Disorder of Skin and/or Subcutaneous Tissue of Trunk
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. It is hypothesized...
Detailed Description
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 (cont...
Eligibility Criteria
Inclusion
- Male or female, ≥ 18 years of age
- Provide signed and dated informed consent form
- Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study
- Willing to follow instructions for incision and drain care, and follow guidelines related to resumption of daily activities
- Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in the study is complete
- 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
- Requiring at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty
- ≤ ASA2 - American Society of Anesthesiologists Physical Classification System (2=subject with mild systemic disease)
- Have a Body Mass Index (BMI) ≤ 28
Exclusion
- Pregnancy or lactation
- Previous abdominoplasty
- Prior bariatric or weight loss surgery
- Lost ≥ 15% of maximum lifetime bodyweight (excluding pregnancy weight gain)
- Known medical condition that results in compromised blood supply to tissues
- Have known or suspected allergy or sensitivity to any test materials or reagents
- Have severe co-morbid conditions (e.g., heart disease)
- Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test
- Any condition known to effect wound healing, such as collagen vascular disease
- Be known to have a blood clotting disorder and/or be willing to discontinue anti-coagulation therapy including aspirin
- Diagnosis of diabetes with current medical treatment
- Receiving antibiotic therapy for pre-existing condition or infection
- Have known personal or family history of keloid formation or hypertrophic scarring
- Currently taking systemic steroids or immunosuppressive agents
- Undergoing concurrent adjacent or congruent Liposuction agents
- Use of pain pumps after the abdominoplasty procedure
- Concurrent use of fibrin sealants or other internal wound care devices
- Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh
- Mini abdominoplasty (abdominoplasty without umbilical transposition)
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01791504
Start Date
March 1 2013
End Date
November 1 2013
Last Update
December 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
Huntersville, North Carolina, United States, 28078