BlepharoptosisNCT00816270
Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty
A study testing Bilateral Upper eyelid blepharoplasty in people with Blepharoptosis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- Bilateral Upper eyelid blepharoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Jul 2008
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 25 years with diagnosis of dermatochalasis who presented surgical indication of primary blepharoplasty.
Who cannot join
- Prior eyelid surgery
- Concomitant ocular or systemic disease or current use of medications that could interfere in coagulation or wound healing (eg, diabetes mellitus, oral acetyl salicylic acid or corticosteroids)
- Pregnant female
- Known allergy to cyanoacrylate
- Inability to return for follow-up consultations
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Ophthalmology of Federal University of Sao Paulo
São Paulo, São Paulo, 04023-900
About this study
Official title: Comparison Between Liquid Bandage(2-Octyl-Cyanoacrylate)and Traditional Suture Closure in Upper Lid Blepharoplasty
The aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery.
Read the detailed description
Tissue adhesives have been safely used in a variety of surgical procedures for several years. Butyl-2-cyanoacrylate (Histoacryl) and Octyl-2-cyanoacrylate (Dermabond) was also studied for cosmetic blepharoplasty with satisfactory results. Liquid Bandage (Johnson \& Johnson, Skillman, NJ, USA) is a more flexible formulation of octyl-2-cyanoacrylate available in many american drugstores for home use. Animal models shown that this product could accelerate the healing of lamellar wounds and studies in humans have demonstrated its safety and effectiveness as an occlusive protective film over cuts, abrasion and wound surgery. Liquid Bandage was also used as a temporary wound barrier in clear corneal cataract surgery with satisfactory applicability. There is no study in the literature using this device in blepharoplasty yet.
- Conditions
- Blepharoptosis
- Being tested
- Bilateral Upper eyelid blepharoplasty
- Keywords
- Blepharoptosis, Dermatochalasis, octyl 2-cyanoacrylate, Suture Techniques, Tissue Adhesive
- Medical subject headings
- Blepharoptosis, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Upper eyelid blepharoplastyProcedure or surgery
Also called Liquid bandage (Johnson & Johnson, Skillman, NJ, USA), nylon continuous sutures (Ethicon, Norderstedt, Germany)
Bilateral upper lid blepharoplasty was performed on each patient by the same experimented surgeon using a standard technique. One side (right or left upper eyelid) was randomly chosen for experimental closure with liquid bandage and the opposite eyelid served as the control being used a 6/0 nylon continuous sutures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental operatory wound closure with liquid bandage (Johnson \& Johnson, Skillman, NJ, USA). Receives: Procedure: Bilateral Upper eyelid blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture).
Measured: thirty days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Experimental results were unsatisfatory compared with control.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharoptosisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Angelino J Cariello, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816270
- Sponsor's protocol ID
- CEP 1716/07
- Status last verified
- Dec 2008
- First submitted
- 31 Dec 2008
- Last updated
- 1 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Veloudios A, Kratky V. Cyanoacrylate Tissue Adhesive in Blepharoplasty. Ophthalm Plastic Reconstr Surg 1996;12(2):89-97. Greene D, Koch RJ, Goode RL. Efficacy of Octyl-2-Cyanoacrylate Tissue Glue in Blepharoplasty. Arch Facial Plast Surg 1999;1:292-6. Davis SC, Eaglstein WH, Cazzaniga AL, Mertz PM. An octyl-2-cyanoacrylate formulation speeds healing of partial-thickness wounds. Dermatol Surg 2001;27:783-8.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Liquid Bandage(2-Octyl-Cyanoacrylate)and Traditional Suture Closure in Upper Lid Blepharoplasty
- ClinicalTrials.gov ID
- NCT00816270
- Acronym / sponsor ID
- CEP 1716/07
- Conditions
- Blepharoptosis
- Keywords
- Blepharoptosis, Dermatochalasis, octyl 2-cyanoacrylate, Suture Techniques, Tissue Adhesive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Experimental results were unsatisfatory compared with control.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Jan 2009 (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 aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery.
Detailed description
Tissue adhesives have been safely used in a variety of surgical procedures for several years. Butyl-2-cyanoacrylate (Histoacryl) and Octyl-2-cyanoacrylate (Dermabond) was also studied for cosmetic blepharoplasty with satisfactory results. Liquid Bandage (Johnson \& Johnson, Skillman, NJ, USA) is a more flexible formulation of octyl-2-cyanoacrylate available in many american drugstores for home use. Animal models shown that this product could accelerate the healing of lamellar wounds and studies in humans have demonstrated its safety and effectiveness as an occlusive protective film over cuts, abrasion and wound surgery. Liquid Bandage was also used as a temporary wound barrier in clear corneal cataract surgery with satisfactory applicability. There is no study in the literature using this device in blepharoplasty yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Bilateral Upper eyelid blepharoplastyExperimental operatory wound closure with liquid bandage (Johnson \& Johnson, Skillman, NJ, USA). |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 25 years with diagnosis of dermatochalasis who presented surgical indication of primary blepharoplasty.
Key exclusion criteria (5 listed)
- Prior eyelid surgery
- Concomitant ocular or systemic disease or current use of medications that could interfere in coagulation or wound healing (eg, diabetes mellitus, oral acetyl salicylic acid or corticosteroids)
- Pregnant female
- Known allergy to cyanoacrylate
- Inability to return for follow-up consultations
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 |
|---|---|---|
| Bilateral Upper eyelid blepharoplastyAlso: Liquid bandage (Johnson & Johnson, Skillman, NJ, USA), nylon continuous sutures (Ethicon, Norderstedt, Germany)Bilateral upper lid blepharoplasty was performed on each patient by the same experimented surgeon using a standard technique. One side (right or left upper eyelid) was randomly chosen for experimental closure with liquid bandage and the opposite eyelid served as the control being used a 6/0 nylon continuous sutures. | Procedure or surgery | 1 |
Primary outcome
The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture).
Time frame: thirty days after surgery
Results and safety
The study was stopped early (reason given: Experimental results were unsatisfatory compared with control.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2009.
- BackgroundVeloudios A, Kratky V. Cyanoacrylate Tissue Adhesive in Blepharoplasty. Ophthalm Plastic Reconstr Surg 1996;12(2):89-97. Greene D, Koch RJ, Goode RL. Efficacy of Octyl-2-Cyanoacrylate Tissue Glue in Blepharoplasty. Arch Facial Plast Surg 1999;1:292-6. Davis SC, Eaglstein WH, Cazzaniga AL, Mertz PM. An octyl-2-cyanoacrylate formulation speeds healing of partial-thickness wounds. Dermatol Surg 2001;27:783-8.
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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.
Angelino J Cariello, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Upper eyelid blepharoplasty in people with Blepharoptosis, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 5 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 1 Jan 2009. 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 Brazil. 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: Experimental results were unsatisfatory compared with control.). 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?
The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture). (time frame: thirty days after surgery). 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 NCT00816270, which also lists 1 linked publication.
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 1 Jan 2009.