Eyelid LacerationPhase 4NCT01918059
Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
A Phase 4 study testing Tissue Adhesive skin closure, Absorbable suture skin closure and Non-absorbable suture skin closure in people with Eyelid Laceration, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Laceration
- What is being tested?
- Tissue Adhesive skin closure, Absorbable suture skin closure and Non-absorbable suture skin closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
- Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Who cannot join
- Eyelid lacerations that include avulsion or missing eyelid tissue
- Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
- Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
- Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair
This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at two intervals after repair and later blindly assessed using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in across all three treatment arms.
Read the detailed description
This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoacrylate). The population will include patients presenting to Memorial Hermann Hospital requiring repair of traumatic lid lacerations. The study will include partial thickness, full-thickness, and margin-involving lacerations where first standard layered tarsal and marginal suture repair will be performed if necessary, and then the patient will be randomized to superficial skin closure with either polypropylene suture closure, surgical gut suture closure, or tissue adhesive closure. Subjects will be followed in an outpatient setting at 1 week and 1 month post-repair at which time standardized photographs will be taken and later assessed using two standardized appearance assessment tools: Visual Analogue Scale (VAS) and Hollander Wound Evaluation Score (HWES).
- Conditions
- Eyelid Laceration
- Being tested
- Tissue Adhesive skin closure, Absorbable suture skin closure, Non-absorbable suture skin closure
- Keywords
- Trauma, Eyelid, Laceration, Tissue adhesive, suture, cosmetic, octyl-2-cyanoacrylate
- Medical subject headings
- Wounds and Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Adhesive skin closureProcedure or surgery
Also called octyl-2-cyanoacrylate, cyanoacrylate, tissue adhesive
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with tissue adhesive (octyl-2-cyanoacrylate).
Absorbable suture skin closureProcedure or surgery
Also called gut, surgical gut
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with absorbable sutures (surgical gut).
Non-absorbable suture skin closureProcedure or surgery
Also called prolene, polypropylene
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with either non-absorbable sutures (6-0 polypropylene).
| Study group | Role | What they receive |
|---|---|---|
| Non-absorbable suture skin closure | Experimental | The superficial eyelid skin will be repaired with simple interrupted sutures with non-absorbable suture (6-0 polypropylene) after repair of any deep component of the laceration. Receives: Procedure: Non-absorbable suture skin closure |
| Absorbable suture skin closure | Experimental | The superficial eyelid skin will be repaired with simple interrupted sutures with absorbable suture (surgical gut) after repair of any deep component of the laceration. Receives: Procedure: Absorbable suture skin closure |
| Tissue Adhesive skin closure | Experimental | The superficial eyelid skin will be repaired with layers of tissue adhesive (octyl-2-cyanoacrylate) after repair of any deep component of the laceration. Receives: Procedure: Tissue Adhesive skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic wound appearance
Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).
Measured: 1 month after repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Eyelid LacerationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judianne Kellaway, The University of Texas Health Science Center, Houston
- Investigators
- Judianne Kellaway, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918059
- Sponsor's protocol ID
- HSC-MS-13-0276
- Status last verified
- Dec 2014
- First submitted
- 30 Jul 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
PubMed 18090752Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31. doi: 10.1016/0735-6757(95)90100-0.
PubMed 7893315Gilbert L, Pogorzalek N, Jounda G, Barreau E. [Traumatic peri-ocular injuries: closing wounds using 2-octyl-cyanoacrylate medical glue]. J Fr Ophtalmol. 2009 May;32(5):341-7. doi: 10.1016/j.jfo.2009.03.024. Epub 2009 May 17. French.
PubMed 19769871Greene D, Koch RJ, Goode RL. Efficacy of octyl-2-cyanoacrylate tissue glue in blepharoplasty. A prospective controlled study of wound-healing characteristics. Arch Facial Plast Surg. 1999 Oct-Dec;1(4):292-6. doi: 10.1001/archfaci.1.4.292.
PubMed 10937118Handschel JG, Depprich RA, Dirksen D, Runte C, Zimmermann A, Kubler NR. A prospective comparison of octyl-2-cyanoacrylate and suture in standardized facial wounds. Int J Oral Maxillofac Surg. 2006 Apr;35(4):318-23. doi: 10.1016/j.ijom.2005.10.003. Epub 2005 Dec 20.
PubMed 16364595Shivamurthy DM, Singh S, Reddy S. Comparison of octyl-2-cyanoacrylate and conventional sutures in facial skin closure. Natl J Maxillofac Surg. 2010 Jan;1(1):15-9. doi: 10.4103/0975-5950.69151.
PubMed 22442543Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. doi: 10.1016/s0196-0644(95)70183-4.
PubMed 7741347
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair
- ClinicalTrials.gov ID
- NCT01918059
- Acronym / sponsor ID
- HSC-MS-13-0276
- Conditions
- Eyelid Laceration
- Keywords
- Trauma, Eyelid, Laceration, Tissue adhesive, suture, cosmetic, octyl-2-cyanoacrylate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Aug 2013 (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.
This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at two intervals after repair and later blindly assessed using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in across all three treatment arms.
Detailed description
This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoacrylate). The population will include patients presenting to Memorial Hermann Hospital requiring repair of traumatic lid lacerations. The study will include partial thickness, full-thickness, and margin-involving lacerations where first standard layered tarsal and marginal suture repair will be performed if necessary, and then the patient will be randomized to superficial skin closure with either polypropylene suture closure, surgical gut suture closure, or tissue adhesive closure. Subjects will be followed in an outpatient setting at 1 week and 1 month post-repair at which time standardized photographs will be taken and later assessed using two standardized appearance assessment tools: Visual Analogue Scale (VAS) and Hollander Wound Evaluation Score (HWES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-absorbable suture skin closure | Experimental | Procedure: Non-absorbable suture skin closureThe superficial eyelid skin will be repaired with simple interrupted sutures with non-absorbable suture (6-0 polypropylene) after repair of any deep component of the laceration. |
| Absorbable suture skin closure | Experimental | Procedure: Absorbable suture skin closureThe superficial eyelid skin will be repaired with simple interrupted sutures with absorbable suture (surgical gut) after repair of any deep component of the laceration. |
| Tissue Adhesive skin closure | Experimental | Procedure: Tissue Adhesive skin closureThe superficial eyelid skin will be repaired with layers of tissue adhesive (octyl-2-cyanoacrylate) after repair of any deep component of the laceration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older.
- Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
- Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Key exclusion criteria (4 listed)
- Eyelid lacerations that include avulsion or missing eyelid tissue
- Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
- Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
- Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair
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 |
|---|---|---|
| Tissue Adhesive skin closureAlso: octyl-2-cyanoacrylate, cyanoacrylate, tissue adhesiveThe approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with tissue adhesive (octyl-2-cyanoacrylate). | Procedure or surgery | Tissue Adhesive skin closure |
| Absorbable suture skin closureAlso: gut, surgical gutThe approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with absorbable sutures (surgical gut). | Procedure or surgery | Absorbable suture skin closure |
| Non-absorbable suture skin closureAlso: prolene, polypropyleneThe approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with either non-absorbable sutures (6-0 polypropylene). | Procedure or surgery | Non-absorbable suture skin closure |
Primary outcome
Cosmetic wound appearance
Time frame: 1 month after repair
Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 18090752Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
- Background: PubMed 7893315Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31. doi: 10.1016/0735-6757(95)90100-0.
- Background: PubMed 19769871Gilbert L, Pogorzalek N, Jounda G, Barreau E. [Traumatic peri-ocular injuries: closing wounds using 2-octyl-cyanoacrylate medical glue]. J Fr Ophtalmol. 2009 May;32(5):341-7. doi: 10.1016/j.jfo.2009.03.024. Epub 2009 May 17. French.
- Background: PubMed 10937118Greene D, Koch RJ, Goode RL. Efficacy of octyl-2-cyanoacrylate tissue glue in blepharoplasty. A prospective controlled study of wound-healing characteristics. Arch Facial Plast Surg. 1999 Oct-Dec;1(4):292-6. doi: 10.1001/archfaci.1.4.292.
- Background: PubMed 16364595Handschel JG, Depprich RA, Dirksen D, Runte C, Zimmermann A, Kubler NR. A prospective comparison of octyl-2-cyanoacrylate and suture in standardized facial wounds. Int J Oral Maxillofac Surg. 2006 Apr;35(4):318-23. doi: 10.1016/j.ijom.2005.10.003. Epub 2005 Dec 20.
- Background: PubMed 22442543Shivamurthy DM, Singh S, Reddy S. Comparison of octyl-2-cyanoacrylate and conventional sutures in facial skin closure. Natl J Maxillofac Surg. 2010 Jan;1(1):15-9. doi: 10.4103/0975-5950.69151.
- Background: PubMed 7741347Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. doi: 10.1016/s0196-0644(95)70183-4.
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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.
Judianne Kellaway, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tissue Adhesive skin closure, Absorbable suture skin closure and Non-absorbable suture skin closure in people with Eyelid Laceration, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 4 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 3 Dec 2014. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Recruitment difficulties). 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?
Cosmetic wound appearance (time frame: 1 month after repair). 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 NCT01918059, which also lists 7 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 3 Dec 2014.