Dehiscence, Surgical WoundNCT00521755
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
A study testing Seraffix LTB in people with Dehiscence, Surgical Wound, run by Seraffix at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dehiscence, Surgical Wound
- What is being tested?
- Seraffix LTB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Feb 2010
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male/Female age 18-60.
- Subject is scheduled for laparoscopic cholecystectomy surgery.
- Subject able to comprehend and give informed consent for participation in this study.
- Signed informed consent form.
Who cannot join
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Bleeding, coagulation and or clotting disorders.
- Diabetes mellitus: IDDM or NIDDM.
- HIV positive or any other immunosuppressive disorder.
- Renal failure (Serum creatinine >2.0 mg/dl).
Show all 19Show fewer
- Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
- Any concomitant infection - viral or bacterial.
- Drug abuse.
- Use of steroids.
- Infection / abscess / pain in treatment target area.
- Pregnancy or lactating.
- History of keloid scarring.
- Use of aspirin or antioxidants
- Subject is suffering extreme general weakness.
- Subject objects to the study protocol.
- Known cognitive or psychiatric disorder
- Concurrent participation in any other clinical study.
- Physician objection.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.
Read the detailed description
Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.
Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues:
- Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
- Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).
Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).
- Conditions
- Dehiscence, Surgical Wound
- Being tested
- Seraffix LTB
- Keywords
- Laser bonding soft tissue albumin
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seraffix LTBDevice
laser soldering for soft tissue wounds
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Seraffix LTB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
Measured: 3 months
Secondary outcomes (1)
1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). 2. Wound dehiscence of at least 50% of wound length:
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehiscence, Surgical WoundStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seraffix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ossama Hatoum, Dr., Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521755
- Sponsor's protocol ID
- SF-01
- Status last verified
- Jun 2009
- First submitted
- 26 Aug 2007
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
- ClinicalTrials.gov ID
- NCT00521755
- Acronym / sponsor ID
- SF-01
- Conditions
- Dehiscence, Surgical Wound
- Keywords
- Laser bonding soft tissue albumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SeraffixIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Aug 2007 (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 evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.
Detailed description
Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.
Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues:
- Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
- Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).
Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Seraffix LTB |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male/Female age 18-60.
- Subject is scheduled for laparoscopic cholecystectomy surgery.
- Subject able to comprehend and give informed consent for participation in this study.
- Signed informed consent form.
Key exclusion criteria (19 listed)
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Bleeding, coagulation and or clotting disorders.
- Diabetes mellitus: IDDM or NIDDM.
- HIV positive or any other immunosuppressive disorder.
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 |
|---|---|---|
| Seraffix LTBlaser soldering for soft tissue wounds | Device | A |
Primary outcome
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
Time frame: 3 months
1 secondary outcome
1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). 2. Wound dehiscence of at least 50% of wound length:
Time frame: 3 months
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 9 Jun 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.
Ossama Hatoum, Dr. principal investigator
HaEmek Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seraffix LTB in people with Dehiscence, Surgical Wound, run by Seraffix at 1 site in Israel.
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 4 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 9 Jun 2011. 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 Israel. 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?
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. (time frame: 3 months). 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 9 Jun 2011.