AbdominoplastyPhase 1/2NCT01331798
Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty
A Phase 1/2 study testing Cohera TissuGlu Surgical Adhesive in people with Abdominoplasty, run by Cohera Medical, Inc. at 3 sites in Germany.
Trial summary
A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Cohera TissuGlu Surgical Adhesive
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2009to May 2010
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 20 years of age;
- 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 requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure, Surgeon must use electrocautery in the procedure;
- Be willing to follow instructions for incision care, comply with schedule for wound drainage volume measurements, and follow guidelines related to resumption of daily activities;
- 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 until their participation in this study is complete; and
- Sign the informed consent.
Who cannot join
- Anesthesia Risk judged to be higher than ASA2
- Previous Abdominoplasty
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised vascular flow to the abdominal wall tissue. Prior abdominal scars, especially subcostal scars, will be a relative contraindication and judged on a case by case basis by the surgeon investigator.
- Any condition known to effect wound healing, such as collagen vascular disease
- Current active tobacco use, including smokeless (chewing) tobacco
Show all 19Show fewer
- Obesity, as defined by BMI >30
- Known blood clotting disorder
- Current diagnosis of diabetes
- Be receiving antibiotic therapy for pre-existing condition or infection
- Have known personal or family history of keloid formation or hypertrophy
- 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
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
- Pregnancy (30 days post-op)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University of Bonn
Bonn
Rosenpark Klinik
Darmstadt
Erich-Lexer-Klinik
Freiburg im Breisgau
About this study
Official title: Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty
A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
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.
Objective: To study the safety and the preliminary efficacy of a TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
Material \& Methods: A blinded prospective randomized trial compared drain fluid output (volume) and complication profile in 40 subjects undergoing abdominoplasty with (n=20) or without (n=20) the use of a urethane based adhesive. The TissuGlu® adhesive, which required no mixing or preparation, was administered to the abdominal wall using a custom drop tip applicator prior to closure of the abdominoplasty flap. Two Blake® drains connected to J-VAC suction reservoirs were placed in the wound.
- Conditions
- Abdominoplasty
- Being tested
- Cohera TissuGlu Surgical Adhesive, Control- Standard of care
- Keywords
- Abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohera TissuGlu Surgical AdhesiveDevice
TissuGlu device used prior to closing of the flap in the abdominoplasty procedure.
Control- Standard of careProcedure or surgery
Control Arm- no TissuGlu device used. Standard abdominoplasty procedure followed.
| Study group | Role | What they receive |
|---|---|---|
| Test: TissuGlu Adhesive | Experimental | Patients received the TissuGlu Adhesive Treatment Receives: Device: Cohera TissuGlu Surgical Adhesive |
| Control | Active comparator | Control Arm received no TissuGlu- Standard of Care received. Receives: Procedure: Control- Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device and non-device related adverse events occurring among study subjects.
Measured: Discharge, 14, 30, 60, 90 Day follow-up
Secondary outcomes (6)
• Time to drain removal based upon a drain removal criteria of <30ml of fluid accumulation in a twenty four (24) hour period (Scevola et al, 2002; Momeni et al, 2008).
Measured: Assessed at time of drain removal- Average 2 to 5 days post surgery.
• Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma
Measured: Discharge, 14, 30, 60, 90 Day follow-up
• Cumulative drainage volume for each patient
Measured: Assessed at time of drain removal- Average 2-5 days post surgery.
• Number of additional physician or clinic visits
Measured: Discharge, 14, 30, 60, 90 Day follow-up
• Number/type of additional procedures due to complications
Measured: Discharge, 14, 30, 60, 90 Day follow-up
• Evaluation of the delivery method/delivery device (Surgeon questionnaire)
Questionnaire completed by the surgeon after the surgery rating ergonomics, visibility, ability to deliver the adhesive and overall satisfaction with the delivery method.
Measured: Assessed at time of surgery/use of the device (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionMay 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331798
- Sponsor's protocol ID
- PRO-100-0002
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT01331798
- Acronym / sponsor ID
- PRO-100-0002
- Conditions
- Abdominoplasty
- Keywords
- Abdominoplasty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Apr 2011 (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.
A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
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.
Objective: To study the safety and the preliminary efficacy of a TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
Material \& Methods: A blinded prospective randomized trial compared drain fluid output (volume) and complication profile in 40 subjects undergoing abdominoplasty with (n=20) or without (n=20) the use of a urethane based adhesive. The TissuGlu® adhesive, which required no mixing or preparation, was administered to the abdominal wall using a custom drop tip applicator prior to closure of the abdominoplasty flap. Two Blake® drains connected to J-VAC suction reservoirs were placed in the wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: TissuGlu Adhesive | Experimental | Device: Cohera TissuGlu Surgical AdhesivePatients received the TissuGlu Adhesive Treatment |
| Control | Active comparator | Procedure: Control- Standard of careControl Arm received no TissuGlu- Standard of Care received. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 20 years of age;
- 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 requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure, Surgeon must use electrocautery in the procedure;
- Be willing to follow instructions for incision care, comply with schedule for wound drainage volume measurements, and follow guidelines related to resumption of daily activities;
- Agree to return for all follow-up evaluations specified in this protocol;
Key exclusion criteria (19 listed)
- Anesthesia Risk judged to be higher than ASA2
- Previous Abdominoplasty
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised vascular flow to the abdominal wall tissue. Prior abdominal scars, especially subcostal scars, will be a relative contraindication and judged on a case by case basis by the surgeon investigator.
- Any condition known to effect wound healing, such as collagen vascular 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 |
|---|---|---|
| Cohera TissuGlu Surgical AdhesiveTissuGlu device used prior to closing of the flap in the abdominoplasty procedure. | Device | Test: TissuGlu Adhesive |
| Control- Standard of careControl Arm- no TissuGlu device used. Standard abdominoplasty procedure followed. | Procedure or surgery | Control |
Primary outcome
• Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device and non-device related adverse events occurring among study subjects.
Time frame: Discharge, 14, 30, 60, 90 Day follow-up
6 secondary outcomes
• Time to drain removal based upon a drain removal criteria of <30ml of fluid accumulation in a twenty four (24) hour period (Scevola et al, 2002; Momeni et al, 2008).
Time frame: Assessed at time of drain removal- Average 2 to 5 days post surgery.
• Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma
Time frame: Discharge, 14, 30, 60, 90 Day follow-up
• Cumulative drainage volume for each patient
Time frame: Assessed at time of drain removal- Average 2-5 days post surgery.
• Number of additional physician or clinic visits
Time frame: Discharge, 14, 30, 60, 90 Day follow-up
• Number/type of additional procedures due to complications
Time frame: Discharge, 14, 30, 60, 90 Day follow-up
• Evaluation of the delivery method/delivery device (Surgeon questionnaire)
Time frame: Assessed at time of surgery/use of the device (Day 0)
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 8 Apr 2011.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cohera TissuGlu Surgical Adhesive in people with Abdominoplasty, run by Cohera Medical, Inc. at 3 sites in Germany.
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 7 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
• Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device and non-device related adverse events occurring among study subjects. (time frame: Discharge, 14, 30, 60, 90 Day follow-up). 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 8 Apr 2011.