PRO-100-0145 - TissuGlu Mastectomy

• Research type

  Research Study

• Full 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.

• IRAS ID

  219556

• Contact name

  Chad Coberly

• Contact email

  ccoberly@coheramed.com

• Sponsor organisation

  Cohera Medical, Inc.

• Clinicaltrials.gov Identifier

  NCT02958449

• Duration of Study in the UK

  0 years, 9 months, 31 days

• Research summary

  The TissuGlu® Mastectomy Study is 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.

  The objective of the study is to compare groups based on the number of Post-Operative Clinical Interventions, where Clinical Intervention is defined as one of the following events:
  1. Removal of an in-dwelling drain (As defined in the Protocol);
  2. Needle aspiration to remove fluid from a Clinically-Relevant Seroma (As defined in the Protocol);
  3. Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures;
  4. Reinsertion or insertion of a drain postoperatively;
  5. Surgical procedures due to wound healing complications related to wound management

  84 Patients with Mastectomy with or without SLNB only (42 test and 42 control) will be enrolled in the UK and Germany. Patients will be randomly assigned to one of the two groups and 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. During the follow-up period, patients will be physically examined, the surgical site is evaluated and a patient questionnaire should be completed.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  17/EM/0014

• Date of REC Opinion

  10 Mar 2017

• REC opinion

  Further Information Favourable Opinion