Dehiscence, Surgical WoundNCT00525434
Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure
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 excisional biopsy wounds closure 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
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Nov 2009
- 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 excisional biopsy 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
Official title: Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System for Excisional Biopsy Wounds Closure
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for excisional biopsy wounds closure
Read the detailed description
Excisional biopsy of the skin is a biopsy in which an entire lesion is removed. An excisional biopsy is in contrast to an incisional biopsy in which only a sample of tissue is cut into and removed. It is most frequently done to diagnose a skin growth such as a mole, or cancer of the skin.
The most common method of wound closure of skin excisions is interrupted nonabsorbable sutures. The sutures should be removed as soon as adequate intrinsic bonding strength is sufficient, depending mostly on the specific body region (from 5-7 days for the face and up to 12-14 days for trunk and extremities).
Laser energy, also known as laser welding, has been used on limited basis as an alternative to traditional wound closure method. 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
wounds closure by using laser and albumin
| 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 excisional biopsy 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 posted5 Sep 2007 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionNov 2009
Why it stopped: sponsor has decide to pospone this study
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seraffix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yehuda Ullmann, Dr., Principal investigator, RAMBAM Medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525434
- Sponsor's protocol ID
- SF-EB -01
- Status last verified
- May 2008
- First submitted
- 4 Sep 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 for Excisional Biopsy Wounds Closure
- ClinicalTrials.gov ID
- NCT00525434
- Acronym / sponsor ID
- SF-EB -01
- Conditions
- Dehiscence, Surgical Wound
- Keywords
- Laser bonding soft tissue albumin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor has decide to pospone this study
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- SeraffixIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Sep 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 excisional biopsy wounds closure
Detailed description
Excisional biopsy of the skin is a biopsy in which an entire lesion is removed. An excisional biopsy is in contrast to an incisional biopsy in which only a sample of tissue is cut into and removed. It is most frequently done to diagnose a skin growth such as a mole, or cancer of the skin.
The most common method of wound closure of skin excisions is interrupted nonabsorbable sutures. The sutures should be removed as soon as adequate intrinsic bonding strength is sufficient, depending mostly on the specific body region (from 5-7 days for the face and up to 12-14 days for trunk and extremities).
Laser energy, also known as laser welding, has been used on limited basis as an alternative to traditional wound closure method. 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 excisional biopsy 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 LTBwounds closure by using laser and albumin | Device | A |
Primary outcome
Primary study endpoint will be to establish the safety of using the Seraffix System for excisional biopsy 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 was stopped early (reason given: sponsor has decide to pospone this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Related trials for Dehiscence, Surgical Wound
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Cerebral Palsy
Recruiting
Skin Staples vs Polypropylene in Elective Laparotomy
Surgical Site Infection
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
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.
Yehuda Ullmann, Dr. principal investigator
RAMBAM Medical Center, Haifa 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: stopped early, 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 was stopped early (reason given: sponsor has decide to pospone this study). Results are not available in the source record.
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 excisional biopsy 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.