Efficacy of a Technique (Brassiere Sutures)NCT02879552
TPS After Upper Blepharoplasty
An observational study of Efficacy of a Technique (Brassiere Sutures), run by Instituto de Olhos de Goiania.
Trial summary
Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS. Read more about this study
- Who is it for?
- Ages 35 to 81 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Efficacy of a Technique (Brassiere Sutures)
- What is being tested?
- Traditional upper blepharoplasty and Brassiere suture with blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- 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 35 to 81 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective, randomized, observational case series study included 110 eyelids (50 patients) that underwent cosmetic upper blepharoplasty and brassiere suture.
Who may be able to join
- Female underwent cosmetic upper blepharoplasty and brassiere suture with blepharoplasty
Who cannot join
- History of thyroid eye disease, levator dehiscence ptosis, blepharospasm, facial nerve paresis, a history of previous upper facial surgery or trauma, and postoperative follow-up for less than 6 months.
About this study
Official title: Tarsal Platform Show After Upper Eyelid Blepharoplasty With or Without Brassiere Sutures
Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.
Read the detailed description
This is a prospective, randomized, comparative, case series study of 100 eyelids (50 consecutive women patients) treated with cosmetic upper blepharoplasty by a single surgeon. Patients were randomized to receive traditional upper blepharoplasty with a single running suture skin closure versus orbicularis oculi muscle fixation to periosteum (brassiere sutures) prior to skin closure. Patient age, follow-up length, complications and treatment were analyzed. The mean of TPS, BFS and TPS/BFS ratio was measured before and after surgery at 3 anatomic landmarks.
56 eyelids (28 patients) were treated with traditional single suture blepharoplasty and 44 eyelids (22 patients) had brassiere sutures. After surgery, the mean change in TPS was 2.10 mm with brassiere sutures compared to 2.04 mm without (p <.001). The mean change in BFS was 3.33 mm with brassiere sutures compared to 3.19 mm without (p <.001), The mean change in TPS:BFS ratio at all 3 anatomic landmarks was statistically significant in both groups but the change was statistically greater with the use of brassiere sutures (p <.001).
Brassiere sutures during upper blepharoplasty were associated with a postoperative increase in TPS decrease in BFS, and increase in TPS/BFS.
- Being tested
- Traditional upper blepharoplasty, Brassiere suture with blepharoplasty
- Keywords
- Upper blepharoplasty, brassiere sutures, tarsal platform show, eyeshadow space, brow fat span
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional upper blepharoplastyProcedure or surgery
The skin incisions were marked using a skin marking pen. Preseptal orbicularis skin and muscle were removed using a size-15 scalpel blade and scissors. Hemostasis was achieved with conservative electrocuatery. The skin was closed with a running 6-0 nylon suture.
Brassiere suture with blepharoplastyProcedure or surgery
Prior to skin closure as above, three 6-0 polyglactin sutures are passed along the lateral fourth of the orbital rim. The sutures attach the inferior orbicularis oculi edge to the arcus marginalis of lateral ROOF. Sutures are placed until there is a visible "plumping" of the sub-brow tissues.
| Study group | Role | What they receive |
|---|---|---|
| Traditional upper blepharoplasty | Patients with an odd total number of letters in their first name received traditional upper blepharoplasty. Receives: Procedure: Brassiere suture with blepharoplasty | |
| Brassiere suture with blepharoplasty | The rest of the patients received orbicularis oculi muscle fixation to periosteum (brassiere sutures) Receives: Procedure: Traditional upper blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid measurements of traditional blepharoplasty and brassiere suture, before and after surgery
Measured: 6 months
Secondary outcomes (1)
Asymmetry of TPS and BFS in traditional blepharoplasty and brassiere suture
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Efficacy of a Technique (Brassiere Sutures)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Referência em Oftalmologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879552
- Sponsor's protocol ID
- MR-01-2016
- Status last verified
- Jul 2016
- First submitted
- 21 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Figueiredo MN, Tao J, Akaishi P, Limongi RM. Tarsal platform show after upper eyelid blepharoplasty with or without brassiere sutures. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):345-349. doi: 10.5935/0004-2749.20170085.
PubMed 29267567
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tarsal Platform Show After Upper Eyelid Blepharoplasty With or Without Brassiere Sutures
- ClinicalTrials.gov ID
- NCT02879552
- Acronym / sponsor ID
- MR-01-2016
- Keywords
- Upper blepharoplasty, brassiere sutures, tarsal platform show, eyeshadow space, brow fat span
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Collaborators
- Centro de Referência em Oftalmologia
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2016 (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.
Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.
Detailed description
This is a prospective, randomized, comparative, case series study of 100 eyelids (50 consecutive women patients) treated with cosmetic upper blepharoplasty by a single surgeon. Patients were randomized to receive traditional upper blepharoplasty with a single running suture skin closure versus orbicularis oculi muscle fixation to periosteum (brassiere sutures) prior to skin closure. Patient age, follow-up length, complications and treatment were analyzed. The mean of TPS, BFS and TPS/BFS ratio was measured before and after surgery at 3 anatomic landmarks.
56 eyelids (28 patients) were treated with traditional single suture blepharoplasty and 44 eyelids (22 patients) had brassiere sutures. After surgery, the mean change in TPS was 2.10 mm with brassiere sutures compared to 2.04 mm without (p <.001). The mean change in BFS was 3.33 mm with brassiere sutures compared to 3.19 mm without (p <.001), The mean change in TPS:BFS ratio at all 3 anatomic landmarks was statistically significant in both groups but the change was statistically greater with the use of brassiere sutures (p <.001).
Brassiere sutures during upper blepharoplasty were associated with a postoperative increase in TPS decrease in BFS, and increase in TPS/BFS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional upper blepharoplasty | – | Procedure: Brassiere suture with blepharoplastyPatients with an odd total number of letters in their first name received traditional upper blepharoplasty. |
| Brassiere suture with blepharoplasty | – | Procedure: Traditional upper blepharoplastyThe rest of the patients received orbicularis oculi muscle fixation to periosteum (brassiere sutures) |
Who may qualify
- Ages
- 35 to 81 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective, randomized, observational case series study included 110 eyelids (50 patients) that underwent cosmetic upper blepharoplasty and brassiere suture.
Key inclusion criteria (1 listed)
- Female underwent cosmetic upper blepharoplasty and brassiere suture with blepharoplasty
Key exclusion criteria (1 listed)
- History of thyroid eye disease, levator dehiscence ptosis, blepharospasm, facial nerve paresis, a history of previous upper facial surgery or trauma, and postoperative follow-up for less than 6 months.
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 |
|---|---|---|
| Traditional upper blepharoplastyThe skin incisions were marked using a skin marking pen. Preseptal orbicularis skin and muscle were removed using a size-15 scalpel blade and scissors. Hemostasis was achieved with conservative electrocuatery. The skin was closed with a running 6-0 nylon suture. | Procedure or surgery | Brassiere suture with blepharoplasty |
| Brassiere suture with blepharoplastyPrior to skin closure as above, three 6-0 polyglactin sutures are passed along the lateral fourth of the orbital rim. The sutures attach the inferior orbicularis oculi edge to the arcus marginalis of lateral ROOF. Sutures are placed until there is a visible "plumping" of the sub-brow tissues. | Procedure or surgery | Traditional upper blepharoplasty |
Primary outcome
Eyelid measurements of traditional blepharoplasty and brassiere suture, before and after surgery
Time frame: 6 months
1 secondary outcome
Asymmetry of TPS and BFS in traditional blepharoplasty and brassiere suture
Time frame: 6 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 25 Aug 2016.
- Derived from this study: PubMed 29267567Figueiredo MN, Tao J, Akaishi P, Limongi RM. Tarsal platform show after upper eyelid blepharoplasty with or without brassiere sutures. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):345-349. doi: 10.5935/0004-2749.20170085.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy of a Technique (Brassiere Sutures), run by Instituto de Olhos de Goiania.
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 1 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Eyelid measurements of traditional blepharoplasty and brassiere suture, before and after surgery (time frame: 6 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 NCT02879552, 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 25 Aug 2016.