Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy
Study Details
Study Description
Brief Summary
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A prospective, randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy. Patients will be enrolled for 90 Days from day of Surgery. It is expected that it will take 6-9 months for the full duration of the study including the 90 day follow up period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test - Standard Closure with TissuGlu Surgical Adhesive Standard closure plus treatment with TissuGlu |
Device: Test - Standard Closure with TissuGlu Surgical Adhesive
Patients randomized into the Test group, TissuGlu® will be applied to the chest wall after removal of the breast tissue using the custom applicator during a standard mastectomy procedure followed by normal wound closure (suturing technique) without drain placement.
|
| No Intervention: Control - Standard Closure Standard closure with no intervention |
Outcome Measures
Primary Outcome Measures
- Number of Post-Operative Clinical Interventions [from day 0 to day 90]
Clinical Intervention is defined as one of the following events: Removal of an in-dwelling drain (As defined in the Protocol); Needle aspiration to remove fluid from a Clinically-Relevant Seroma (As defined in the Protocol); Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; Reinsertion or insertion of a drain post operatively; Surgical procedures due to wound healing complications related to wound management
Secondary Outcome Measures
- Wound healing related complications [Day 1, 5, 14, 30, 90]
- Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume) [Day 1, 5, 14, 30, 90]
- Days to drain removal [Day 1, 5, 14, 30, 90]
- Cumulative days of treatment (with drains or aspiration) [Day 1, 5, 14, 30, 90]
- Days to discharge from hospital [Day 1, 5, 14, 30, 90]
- Number of Clinically Relevant Seromas formation (number and aspiration volume) [Day 1, 5, 14, 30, 90]
- Incidence and timing of initiation of adjuvant therapy related to the mastectomy procedure (such as radiation therapy, chemotherapy, endocrine therapy) [Day 1, 5, 14, 30, 90]
- Patient Benefit Questionnaire [Day 1, 5, 14, 30, 90]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 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 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 this 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 a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy;
-
≤ ASA 3 - American Society of Anesthesiologists Physical Classification System
Exclusion Criteria:
-
Pregnancy or lactation;
-
Known medical condition that results in compromised blood supply to tissues;
-
Known or suspected allergy or sensitivity to any test materials or reagents;
-
Any condition known to affect wound healing, such as collagen vascular disease;
-
Receiving antibiotic therapy for pre-existing condition or infection;
-
Planned immediate breast reconstruction;
-
Concurrent use of fibrin sealants or other internal wound care devices;
-
Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study;
-
Requiring a mastectomy with ALND (as determined at time of surgery);
-
Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Cologne Holweide | Cologne | Germany | ||
| 2 | University Hospital Cologne St. Elisabeth | Cologne | Germany | ||
| 3 | University Hospital Erlangen | Erlangen | Germany | ||
| 4 | University Hospital Greifswald | Greifswald | Germany | ||
| 5 | Royal Cornwall Hospital | Cornwall | United Kingdom | ||
| 6 | Derby Teaching Hospitals NHS Foundation Trust | Derby | United Kingdom | ||
| 7 | University Hospitals of Leicester NHS Foundation Trust | Leicester | United Kingdom | ||
| 8 | Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom | ||
| 9 | Royal Hallamshire Hospital | Sheffield | United Kingdom | ||
| 10 | St. Helens & Knowsley Teaching Hospitals NHS Trust | St Helens | United Kingdom |
Sponsors and Collaborators
- Cohera Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-100-0145