Status:
COMPLETED
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
Lead Sponsor:
Cohera Medical, Inc.
Conditions:
Abdominoplasty
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief 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 abdominoplast...
Detailed 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 ris...
Eligibility Criteria
Inclusion
- Be at least 18 years of age;
- BMI ≤ 35;
- ≤ ASA2 - American Society of Anesthesiologists (ASA) Physical Classification System (2=patient with mild systemic disease);
- 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.
- Be willing to follow instructions for incision care, wound exudates volume measurements, and diary completion as instructed by the investigator, 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 on the abdomen, until their participation in this study is complete; and
- Sign the informed consent
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01526954
Start Date
April 1 2012
End Date
November 1 2013
Last Update
December 5 2013
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