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NCT Number: NCT02958449

Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy

Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Cologne Holweide, Cologne, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test - Standard Closure with TissuGlu Surgical Adhesive

Device

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.

Primary outcomes

  1. Number of Post-Operative Clinical Interventions

    Time frame: 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 outcomes

  1. Wound healing related complications

    Time frame: Day 1, 5, 14, 30, 90

  2. Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)

    Time frame: Day 1, 5, 14, 30, 90

  3. Days to drain removal

    Time frame: Day 1, 5, 14, 30, 90

  4. Cumulative days of treatment (with drains or aspiration)

    Time frame: Day 1, 5, 14, 30, 90

  5. Days to discharge from hospital

    Time frame: Day 1, 5, 14, 30, 90

  6. Number of Clinically Relevant Seromas formation (number and aspiration volume)

    Time frame: Day 1, 5, 14, 30, 90

  7. Incidence and timing of initiation of adjuvant therapy related to the mastectomy procedure (such as radiation therapy, chemotherapy, endocrine therapy)

    Time frame: Day 1, 5, 14, 30, 90

  8. Patient Benefit Questionnaire

    Time frame: Day 1, 5, 14, 30, 90

Sponsors and collaborators

Lead sponsor

Cohera Medical, Inc.

Industry

Registry information

Official study title

Prospective Clinical Investigation for a 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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