Disorder of Skin and/or Subcutaneous Tissue of TrunkPhase 2/3NCT01791504
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
A Phase 2/3 study testing TissuGlu Surgical Adhesive in people with Disorder of Skin and/or Subcutaneous Tissue of Trunk, run by Cohera Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder of Skin and/or Subcutaneous Tissue of Trunk
- What is being tested?
- TissuGlu Surgical Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2013
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ≥ 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 and drain 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 the 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
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- Requiring at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty
- ≤ ASA2 - American Society of Anesthesiologists Physical Classification System (2=subject with mild systemic disease)
- Have a Body Mass Index (BMI) ≤ 28
Who cannot join
- Pregnancy or lactation
- Previous abdominoplasty
- Prior bariatric or weight loss surgery
- Lost ≥ 15% of maximum lifetime bodyweight (excluding pregnancy weight gain)
- Known medical condition that results in compromised blood supply to tissues
- Have known or suspected allergy or sensitivity to any test materials or reagents
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- Have severe co-morbid conditions (e.g., heart disease)
- Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test
- Any condition known to effect wound healing, such as collagen vascular disease
- 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
- Receiving antibiotic therapy for pre-existing condition or infection
- Have known personal or family history of keloid formation or hypertrophic scarring
- Currently taking systemic steroids or immunosuppressive agents
- Undergoing concurrent adjacent or congruent Liposuction agents
- Use of pain pumps after the abdominoplasty procedure
- Concurrent use of fibrin sealants or other internal wound care devices
- Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh
- Mini abdominoplasty (abdominoplasty without umbilical transposition)
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
Huntersville, North Carolina, 28078
About this study
Official title: A Clinical Investigation for a Randomized Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques Plus TissuGlu® and No Drains (Test) During Abdominoplasty
The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. 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.
Read the detailed description
The Cohera TissuGlu® study is a pivotal, prospective clinical investigation for a randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques plus TissuGlu® and no drains (test) during abdominoplasty. TissuGlu® will be applied to the test group prior to standard closure of the abdominal flap thereby eliminating the deadspace between the fascia and the flap. No closed suction drains will be inserted in the test group. The control group will receive closed suction drains per the standard of care. It is hypothesized that the elimination of deadspace in the wound in the test group will prevent post-surgical fluid from developing and causing seroma and that the number of invasive treatments related to aspirations in the test group will not be inferior to the management and removal of drains and aspirations for seroma in the control group. The study will be conducted with 130 patients (65 test, 65 control) at up to 5 sites.
- Being tested
- TissuGlu Surgical Adhesive
- Keywords
- Abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuGlu Surgical AdhesiveDevice
Standard Wound Closure Techniques Plus TissuGlu and no drains.
| Study group | Role | What they receive |
|---|---|---|
| TissuGlu Surgical Adhesive | Experimental | Standard wound closure techniques plus TissuGlu and no drains. Receives: Device: TissuGlu Surgical Adhesive |
| Control - Standard of Care | No intervention | Standard wound closure techniques with drains. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Post-Operative Invasive Treatments
Number of Post-Operative Invasive Treatments, where Invasive Treatment is defined as one of the following events:
- Removal of an in-dwelling drain;
- Needle aspiration to remove fluid from a clinically-diagnosed palpable seroma;
- Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures;
- Reinsertion of a drain
Measured: 90 Days
Secondary outcomes (1)
Secondary Outcome Measures
- Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Measured: 90 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Skin and/or Subcutaneous Tissue of TrunkStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Hunstad, MD, Principal investigator, The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791504
- Sponsor's protocol ID
- PRO-100-0085
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation for a Randomized Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques Plus TissuGlu® and No Drains (Test) During Abdominoplasty
- ClinicalTrials.gov ID
- NCT01791504
- Acronym / sponsor ID
- PRO-100-0085
- Keywords
- Abdominoplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Feb 2013 (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.
The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. 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.
Detailed description
The Cohera TissuGlu® study is a pivotal, prospective clinical investigation for a randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques plus TissuGlu® and no drains (test) during abdominoplasty. TissuGlu® will be applied to the test group prior to standard closure of the abdominal flap thereby eliminating the deadspace between the fascia and the flap. No closed suction drains will be inserted in the test group. The control group will receive closed suction drains per the standard of care. It is hypothesized that the elimination of deadspace in the wound in the test group will prevent post-surgical fluid from developing and causing seroma and that the number of invasive treatments related to aspirations in the test group will not be inferior to the management and removal of drains and aspirations for seroma in the control group. The study will be conducted with 130 patients (65 test, 65 control) at up to 5 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TissuGlu Surgical Adhesive | Experimental | Device: TissuGlu Surgical AdhesiveStandard wound closure techniques plus TissuGlu and no drains. |
| Control - Standard of Care | No intervention | –Standard wound closure techniques with drains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, ≥ 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 and drain 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 the study is complete
Key exclusion criteria (20 listed)
- Pregnancy or lactation
- Previous abdominoplasty
- Prior bariatric or weight loss surgery
- Lost ≥ 15% of maximum lifetime bodyweight (excluding pregnancy weight gain)
- Known medical condition that results in compromised blood supply to tissues
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 |
|---|---|---|
| TissuGlu Surgical AdhesiveStandard Wound Closure Techniques Plus TissuGlu and no drains. | Device | TissuGlu Surgical Adhesive |
Primary outcome
Number of Post-Operative Invasive Treatments
Time frame: 90 Days
Number of Post-Operative Invasive Treatments, where Invasive Treatment is defined as one of the following events: * Removal of an in-dwelling drain; * Needle aspiration to remove fluid from a clinically-diagnosed palpable seroma; * Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; * Reinsertion of a drain
1 secondary outcome
Secondary Outcome Measures
Time frame: 90 Day
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 5 Dec 2013.
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.
Joseph Hunstad, MD principal investigator
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TissuGlu Surgical Adhesive in people with Disorder of Skin and/or Subcutaneous Tissue of Trunk, run by Cohera Medical, Inc. at 1 site in United States.
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 9 inclusion and 20 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 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Invasive Treatments (time frame: 90 Days). 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 5 Dec 2013.