AbdominoplastyPhase 2/3NCT01526954
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
A Phase 2/3 study testing TissuGlu Surgical Adhesive in people with Abdominoplasty, run by Cohera Medical, Inc..
Trial summary
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age;
- BMI ≤ 35;
- ≤ ASA2 - American Society of Anesthesiologists (ASA) Physical Classification System (2=patient with mild systemic disease);
- Be 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;
- Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty.
- Be willing to follow instructions for incision care, wound exudates volume measurements, and diary completion as instructed by the investigator, and follow guidelines related to resumption of daily activities;
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- Agree to return for all follow-up evaluations specified in this protocol
- Agree not to schedule any additional elective surgical procedures that involve an incision on the abdomen, until their participation in this study is complete; and
- Sign the informed consent
Who cannot join
- Pregnant or breastfeeding
- Previous abdominoplasty;
- Concurrent liposuction during procedure;
- Use of pain pumps;
- Have severe co-morbid conditions (e.g., heart disease);
- Known medical condition that results in compromised blood supply to tissues;
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- Any condition known to effect wound healing, such as collagen vascular disease;
- Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test;
- 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;
- Be receiving antibiotic therapy for pre-existing condition or infection;
- Have known personal or family history of keloid formation or hypertrophic scarring;
- Undergoing concurrent adjacent or congruent Liposuction procedures;
- Concurrent use of fibrin sealants or other internal wound care devices;
- Be currently taking systemic steroids or immunosuppressive agents;
- Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh;
- Mini abdominoplasty (Abdominoplasty without umbilical transposition);
- Have known or suspected allergy or sensitivity to any test materials or reagents; and
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study.
About this study
Official title: A Prospective, Randomized, Controlled, Single-blind, Multicenter Clinical Trial Evaluating the Safety and Efficacy of the Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage as Compared to the Standard of Care Closure Techniques Following Abdominoplasty
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). 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
Background:
Fluid accumulation in dissected tissue planes has been a longstanding problem following surgical procedures. The common use of closed suction drains has been associated with infection risk, wound healing complications, additional scarring, and patient discomfort. Additionally, seroma formation after drain removal often requires invasive treatment. Therapies that can reduce fluid accumulation and decrease the need for drains will have a positive impact on surgical practice.
Objectives:
- To establish that the use of TissuGlu® Surgical Adhesive is a safe and effective alternative to drains (standard of care) for fluid management following abdominoplasty.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative invasive treatments, and seroma formation.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative subject satisfaction and quality of life.
- To document the type and duration of adverse events associated with TissuGlu® used during an abdominoplasty procedure as an alternative to drains.
Material and Methods:
A prospective randomized trial comparing standard wound closure technique with drains in 130 subjects (control group n=65) to standard wound closure techniques plus TissuGlu® and no drains (test group n=65) during Abdominoplasty.
For subjects randomized into the Test Group, TissuGlu® will be applied to one surface of the exposed tissue flap using the custom applicator during a standard abdominoplasty procedure followed by normal wound closure (suturing technique) without drain placement. The applicator device will deliver an array of drops spaced equidistant apart. The user may then reposition the device to the next area and repeat the application process. Each device will dispense approximately 5 ml of adhesive. It is expected that one 5 ml device will suffice for the average sized subject (400-500 sq cm tissue flap). The TissuGlu® is applied using the disposable applicator to the tissue surfaces to be adhered just prior to standard closure. The tissue is then approximated, and the wound is closed using standard suturing techniques. TissuGlu® will begin to cure upon exposure to moisture in the tissue. The cure process takes approximately 30-45 minutes.
Subjects that are randomized to the Control Group will undergo normal wound closure (suturing technique) and placement of two size 12 Blake drains.
- Conditions
- Abdominoplasty
- Being tested
- TissuGlu Surgical Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuGlu Surgical AdhesiveDevice
TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.
| Study group | Role | What they receive |
|---|---|---|
| TissuGlu Surgical Adhesive | Experimental | Experimental Arm: standard of care plus TissuGlu Surgical Adhesive and no drains Receives: Device: TissuGlu Surgical Adhesive |
| Control- Standard of Care | No intervention | Control Arm: standard of care plus drains and no TissuGlu Surgical Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach drain removal criteria.
Primary efficacy endpoint is time (days) to reach drain removal criteria of less than 30ml per 24hr period.
Measured: Measured until drains are removed, up to 30 days post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startApr 2012
- 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 AbdominoplastyStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 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
- NCT01526954
- Sponsor's protocol ID
- PRO-100-0003
- Status last verified
- Dec 2013
- First submitted
- 31 Jan 2012
- Last updated
- 5 Dec 2013
- Results posted
- 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 Prospective, Randomized, Controlled, Single-blind, Multicenter Clinical Trial Evaluating the Safety and Efficacy of the Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage as Compared to the Standard of Care Closure Techniques Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT01526954
- Acronym / sponsor ID
- PRO-100-0003
- Conditions
- Abdominoplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Feb 2012 (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.
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). 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
Background:
Fluid accumulation in dissected tissue planes has been a longstanding problem following surgical procedures. The common use of closed suction drains has been associated with infection risk, wound healing complications, additional scarring, and patient discomfort. Additionally, seroma formation after drain removal often requires invasive treatment. Therapies that can reduce fluid accumulation and decrease the need for drains will have a positive impact on surgical practice.
Objectives:
- To establish that the use of TissuGlu® Surgical Adhesive is a safe and effective alternative to drains (standard of care) for fluid management following abdominoplasty.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative invasive treatments, and seroma formation.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative subject satisfaction and quality of life.
- To document the type and duration of adverse events associated with TissuGlu® used during an abdominoplasty procedure as an alternative to drains.
Material and Methods:
A prospective randomized trial comparing standard wound closure technique with drains in 130 subjects (control group n=65) to standard wound closure techniques plus TissuGlu® and no drains (test group n=65) during Abdominoplasty.
For subjects randomized into the Test Group, TissuGlu® will be applied to one surface of the exposed tissue flap using the custom applicator during a standard abdominoplasty procedure followed by normal wound closure (suturing technique) without drain placement. The applicator device will deliver an array of drops spaced equidistant apart. The user may then reposition the device to the next area and repeat the application process. Each device will dispense approximately 5 ml of adhesive. It is expected that one 5 ml device will suffice for the average sized subject (400-500 sq cm tissue flap). The TissuGlu® is applied using the disposable applicator to the tissue surfaces to be adhered just prior to standard closure. The tissue is then approximated, and the wound is closed using standard suturing techniques. TissuGlu® will begin to cure upon exposure to moisture in the tissue. The cure process takes approximately 30-45 minutes.
Subjects that are randomized to the Control Group will undergo normal wound closure (suturing technique) and placement of two size 12 Blake drains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TissuGlu Surgical Adhesive | Experimental | Device: TissuGlu Surgical AdhesiveExperimental Arm: standard of care plus TissuGlu Surgical Adhesive and no drains |
| Control- Standard of Care | No intervention | –Control Arm: standard of care plus drains and no TissuGlu Surgical Adhesive |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be at least 18 years of age;
- BMI ≤ 35;
- ≤ ASA2 - American Society of Anesthesiologists (ASA) Physical Classification System (2=patient with mild systemic disease);
- Be 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;
- Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty.
Key exclusion criteria (19 listed)
- Pregnant or breastfeeding
- Previous abdominoplasty;
- Concurrent liposuction during procedure;
- Use of pain pumps;
- Have severe co-morbid conditions (e.g., heart disease);
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 AdhesiveTissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases. | Device | TissuGlu Surgical Adhesive |
Primary outcome
Time to reach drain removal criteria.
Time frame: Measured until drains are removed, up to 30 days post-op.
Primary efficacy endpoint is time (days) to reach drain removal criteria of less than 30ml per 24hr period.
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.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TissuGlu Surgical Adhesive in people with Abdominoplasty, run by Cohera Medical, Inc..
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 19 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.
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?
Time to reach drain removal criteria. (time frame: Measured until drains are removed, up to 30 days post-op.). 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.