LacerationssutvsgluNCT00524888
Suturing vs Biological Adhesive in Simple Lacerations of Hand
A study testing suturing laceration and bioadhesive in people with Lacerations, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lacerations
- What is being tested?
- suturing laceration and bioadhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age
- Hand laceration distal to the volar wrist crease.
Who cannot join
- Fracture , tendon, artery involvement, more than 8 hours from laceration to trx,
- Immunosuppression
- Anticoagulation therapy
- Diabetes
- Unable to achieve homeostasis in more than 15 minutes
- Unwilling to participate in the study
- Unable to participate in the follow up or bite of any kind.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 0097226776095, arik@hadassah.org.il
Hadas Lemberg, 00972256777572, lhadas@hadassah.org.il
About this study
Official title: Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study
To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.
- Conditions
- Lacerations
- Being tested
- suturing laceration, bioadhesive
- Keywords
- Hand, Laceration, bioadhesive, ER, Hand laceration distal to the volar wrist crease
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturing lacerationProcedure or surgery
suturing simple lacerations of the hand
bioadhesiveProcedure or surgery
using bioadhesive on simple lacerations of the hand
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | suturing lacerations of the hand Receives: Procedure: suturing laceration |
| 2 | Active comparator | using bioadhesive on lacerations of hand Receives: Procedure: bioadhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound appearance
Measured: 3 Months
Secondary outcomes (1)
pain of treatment and time length of treatment
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 startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael Icekson, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524888
- Sponsor's protocol ID
- sutvsglu-HMO-CTIL
- Acronym
- sutvsglu
- Status last verified
- Aug 2007
- First submitted
- 4 Sep 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00524888
- Acronym / sponsor ID
- sutvsglu / sutvsglu-HMO-CTIL
- Conditions
- Lacerations
- Keywords
- Hand, Laceration, bioadhesive, ER, Hand laceration distal to the volar wrist crease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2007
- 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.
To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: suturing lacerationsuturing lacerations of the hand |
| 2 | Active comparator | Procedure: bioadhesiveusing bioadhesive on lacerations of hand |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any age
- Hand laceration distal to the volar wrist crease.
Key exclusion criteria (7 listed)
- Fracture , tendon, artery involvement, more than 8 hours from laceration to trx,
- Immunosuppression
- Anticoagulation therapy
- Diabetes
- Unable to achieve homeostasis in more than 15 minutes
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 |
|---|---|---|
| suturing lacerationsuturing simple lacerations of the hand | Procedure or surgery | 1 |
| bioadhesiveusing bioadhesive on simple lacerations of the hand | Procedure or surgery | 2 |
Primary outcome
Wound appearance
Time frame: 3 Months
1 secondary outcome
pain of treatment and time length of treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2007.
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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.
Michael Icekson, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suturing laceration and bioadhesive in people with Lacerations, run by Hadassah Medical Organization 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound appearance (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 5 Sep 2007.