Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage

NCT01526954 | Completed Phase 2

• 1 other identifier: PRO-100-0003
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Time to reach drain removal criteria.

  Primary efficacy endpoint is time (days) to reach drain removal criteria of less than 30ml per 24hr period.

  Measured until drains are removed, up to 30 days post-op.

Study Arms (2)

TissuGlu Surgical Adhesive

EXPERIMENTAL

Experimental Arm: standard of care plus TissuGlu Surgical Adhesive and no drains

Device: TissuGlu Surgical Adhesive

Control- Standard of Care

NO INTERVENTION

Control Arm: standard of care plus drains and no TissuGlu Surgical Adhesive

Interventions

TissuGlu Surgical Adhesive DEVICE

TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.

TissuGlu Surgical Adhesive

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding
• Previous abdominoplasty;
• Concurrent liposuction during procedure;
• Use of pain pumps;
• Have severe co-morbid conditions (e.g., heart disease);
• Known medical condition that results in compromised blood supply to tissues;
• Any condition known to effect wound healing, such as collagen vascular disease;
• Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test;
• 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;
• Be receiving antibiotic therapy for pre-existing condition or infection;
• Have known personal or family history of keloid formation or hypertrophic scarring;
• 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;

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 6, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12