WoundPhase 1NCT02149979
Closure of Skin Incision Using CO2 Laser
A Phase 1 study of Wound, run by Avraham Katzir at 2 sites in Israel.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2007to Jan 2009
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female age 18-65.
- Subject is scheduled for laparoscopic cholecystectomy surgery.
- Subject able to comprehend and sign informed consent for participation in this study.
- Ability to comply with the study procedures and follow-up visits
Who cannot join
- Subject has a history of hypertrophic or keloid scar formation
- Subject is a pregnant and/or nursing woman
- Subject has a known allergy to blood products
- Subject is suffering from a bleeding disorders or using anticoagulant medications
- Subject is suffering from hepatic or renal disorder
- Subject is suffering from rheumatic and / or collagen disorder
Show all 13Show fewer
- Subject is using steroids
- Subject is suffering from immunosuppressive disorder
- Subject is suffering from Ischemic Heart Disease (IHD)
- Subject is suffering from neoplastic disorder
- Subject who has had an active illness within 4 weeks of study enrollment
- Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Department of Surgery B, "HaEmek" Medical Center
Afula, 18341
Haemek Medical Center
Afula, 18341
About this study
The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.
Read the detailed description
Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.
The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.
This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.
- Conditions
- Wound
- Being tested
- Temperature Controlled Laser Soldering
- Keywords
- Incision, Wound Closure, Laser Tissue Soldering
- Medical subject headings
- Wounds and Injuries, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature Controlled Laser SolderingDevice
This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.
| Study group | Role | What they receive |
|---|---|---|
| Temperature Controlled Laser Soldering | Experimental | Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure Receives: Device: Temperature Controlled Laser Soldering |
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 Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 3 months
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 posted29 May 2014 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avraham Katzir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Avraham Katzir, Tel Aviv University
- Investigators
- Doron Kopelman, MD, Principal investigator, Department of Surgery B, "HaEmek" Medical Center, Afula,Abraham Katzir, PhD, Study chair, The applied physics group, Tel Aviv UniversityDavid Simhon, MD, PhD, Study director, The applied physics group, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149979
- Sponsor's protocol ID
- Katzir #1
- Status last verified
- May 2014
- First submitted
- 25 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Simhon D, Halpern M, Brosh T, Vasilyev T, Ravid A, Tennenbaum T, Nevo Z, Katzir A. Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin. Ann Surg. 2007 Feb;245(2):206-13. doi: 10.1097/01.sla.0000232554.13719.10.
PubMed 17245173Simhon D, Brosh T, Halpern M, Ravid A, Vasilyev T, Kariv N, Katzir A, Nevo Z. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern. Lasers Surg Med. 2004;35(1):1-11. doi: 10.1002/lsm.20074.
PubMed 15278922Brosh T, Simhon D, Halpern M, Ravid A, Vasilyev T, Kariv N, Nevo Z, Katzir A. Closure of skin incisions in rabbits by laser soldering II: Tensile strength. Lasers Surg Med. 2004;35(1):12-7. doi: 10.1002/lsm.20073.
PubMed 15278923Simhon D, Ravid A, Halpern M, Cilesiz I, Brosh T, Kariv N, Leviav A, Katzir A. Laser soldering of rat skin, using fiberoptic temperature controlled system. Lasers Surg Med. 2001;29(3):265-73. doi: 10.1002/lsm.1118.
PubMed 11573230
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Skin Incision Using CO2 Laser
- ClinicalTrials.gov ID
- NCT02149979
- Acronym / sponsor ID
- Katzir #1
- Conditions
- Wound
- Keywords
- Incision, Wound Closure, Laser Tissue Soldering
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Avraham KatzirUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 May 2014 (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 Temperature Controlled Laser Soldering System for soft tissue bonding.
Detailed description
Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.
The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.
This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature Controlled Laser Soldering | Experimental | Device: Temperature Controlled Laser SolderingEfficacy and safety of Temperature Controlled Laser Soldered wound incisions closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/Female age 18-65.
- Subject is scheduled for laparoscopic cholecystectomy surgery.
- Subject able to comprehend and sign informed consent for participation in this study.
- Ability to comply with the study procedures and follow-up visits
Key exclusion criteria (13 listed)
- Subject has a history of hypertrophic or keloid scar formation
- Subject is a pregnant and/or nursing woman
- Subject has a known allergy to blood products
- Subject is suffering from a bleeding disorders or using anticoagulant medications
- Subject is suffering from hepatic or renal 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 |
|---|---|---|
| Temperature Controlled Laser SolderingThis study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system. | Device | Temperature Controlled Laser Soldering |
Primary outcome
Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
Time frame: 3 months
2 secondary outcomes
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).
Time frame: 3 months
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 29 May 2014.
- Background: PubMed 17245173Simhon D, Halpern M, Brosh T, Vasilyev T, Ravid A, Tennenbaum T, Nevo Z, Katzir A. Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin. Ann Surg. 2007 Feb;245(2):206-13. doi: 10.1097/01.sla.0000232554.13719.10.
- Background: PubMed 15278922Simhon D, Brosh T, Halpern M, Ravid A, Vasilyev T, Kariv N, Katzir A, Nevo Z. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern. Lasers Surg Med. 2004;35(1):1-11. doi: 10.1002/lsm.20074.
- Background: PubMed 15278923Brosh T, Simhon D, Halpern M, Ravid A, Vasilyev T, Kariv N, Nevo Z, Katzir A. Closure of skin incisions in rabbits by laser soldering II: Tensile strength. Lasers Surg Med. 2004;35(1):12-7. doi: 10.1002/lsm.20073.
- Background: PubMed 11573230Simhon D, Ravid A, Halpern M, Cilesiz I, Brosh T, Kariv N, Leviav A, Katzir A. Laser soldering of rat skin, using fiberoptic temperature controlled system. Lasers Surg Med. 2001;29(3):265-73. doi: 10.1002/lsm.1118.
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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.
Doron Kopelman, MD principal investigator
Department of Surgery B, "HaEmek" Medical Center, Afula,
Abraham Katzir, PhD study chair
The applied physics group, Tel Aviv University
David Simhon, MD, PhD study director
The applied physics group, Tel Aviv University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Wound, run by Avraham Katzir at 2 sites 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 13 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this 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.
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?
Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin 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?
On the ClinicalTrials.gov record for NCT02149979, which also lists 4 linked publications.
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 May 2014.