Cancer, BreastNCT02958449
Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy
A study testing Test - Standard Closure with TissuGlu Surgical Adhesive in people with Cancer, Breast, run by Cohera Medical, Inc. at 10 sites in 2 countries.
Trial summary
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- Test - Standard Closure with TissuGlu Surgical Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom6 sites
Royal Cornwall Hospital
Cornwall
Derby Teaching Hospitals NHS Foundation Trust
Derby
University Hospitals of Leicester NHS Foundation Trust
Leicester
Nottingham University Hospitals NHS Trust
Nottingham
Royal Hallamshire Hospital
Sheffield
St. Helens & Knowsley Teaching Hospitals NHS Trust
St Helens
Germany4 sites
University Hospital Cologne Holweide
Cologne
University Hospital Cologne St. Elisabeth
Cologne
University Hospital Erlangen
Erlangen
University Hospital Greifswald
Greifswald
About this study
Official 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
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
Read the 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.
- Conditions
- Cancer, Breast
- Being tested
- Test - Standard Closure with TissuGlu Surgical Adhesive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test - Standard Closure with TissuGlu Surgical AdhesiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test - Standard Closure with TissuGlu Surgical Adhesive | Experimental | Standard closure plus treatment with TissuGlu Receives: Device: Test - Standard Closure with TissuGlu Surgical Adhesive |
| Control - Standard Closure | No intervention | Standard closure with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Post-Operative Clinical Interventions
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
Measured: from day 0 to day 90
Secondary outcomes (8)
Wound healing related complications
Measured: Day 1, 5, 14, 30, 90
Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Measured: Day 1, 5, 14, 30, 90
Days to drain removal
Measured: Day 1, 5, 14, 30, 90
Cumulative days of treatment (with drains or aspiration)
Measured: Day 1, 5, 14, 30, 90
Days to discharge from hospital
Measured: Day 1, 5, 14, 30, 90
Number of Clinically Relevant Seromas formation (number and aspiration volume)
Measured: 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)
Measured: Day 1, 5, 14, 30, 90
Patient Benefit Questionnaire
Measured: Day 1, 5, 14, 30, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958449
- Sponsor's protocol ID
- PRO-100-0145
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02958449
- Acronym / sponsor ID
- PRO-100-0145
- Conditions
- Cancer, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test - Standard Closure with TissuGlu Surgical Adhesive | Experimental | Device: Test - Standard Closure with TissuGlu Surgical AdhesiveStandard closure plus treatment with TissuGlu |
| Control - Standard Closure | No intervention | –Standard closure with no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test - Standard Closure with TissuGlu Surgical AdhesivePatients 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. | Device | Test - Standard Closure with TissuGlu Surgical Adhesive |
Primary outcome
Number of Post-Operative Clinical Interventions
Time frame: from day 0 to day 90
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 post operatively; 5. Surgical procedures due to wound healing complications related to wound management
8 secondary outcomes
Wound healing related complications
Time frame: Day 1, 5, 14, 30, 90
Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Time frame: Day 1, 5, 14, 30, 90
Days to drain removal
Time frame: Day 1, 5, 14, 30, 90
Cumulative days of treatment (with drains or aspiration)
Time frame: Day 1, 5, 14, 30, 90
Days to discharge from hospital
Time frame: Day 1, 5, 14, 30, 90
Number of Clinically Relevant Seromas formation (number and aspiration volume)
Time frame: 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)
Time frame: Day 1, 5, 14, 30, 90
Patient Benefit Questionnaire
Time frame: Day 1, 5, 14, 30, 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test - Standard Closure with TissuGlu Surgical Adhesive in people with Cancer, Breast, run by Cohera Medical, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Post-Operative Clinical Interventions (time frame: from day 0 to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.