Reconstructive Surgical ProcedureNCT03712995
Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf
A study testing 'Cutler-Beard modified with graft' in people with Reconstructive Surgical Procedure, run by Hospital Universitario 12 de Octubre.
Trial summary
To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Reconstructive Surgical Procedure
- What is being tested?
- 'Cutler-Beard modified with graft'
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper eyelid defect after tumor resection
Who cannot join
- previous surgery
About this study
Official title: Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft
To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid
Read the detailed description
A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.
Functional, cosmetic outcomes and postoperative complications were evaluated.
- Conditions
- Reconstructive Surgical Procedure
- Being tested
- 'Cutler-Beard modified with graft'
- Keywords
- Cutler-Beard, tarsoconjunctival graft, upper eyelid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Cutler-Beard modified with graft'Procedure or surgery
Also called Modified Cutler-Beard technique with tarsoconjunctival graft
A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.
| Study group | Role | What they receive |
|---|---|---|
| Cutler-Beard modified with graft | Experimental | Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf Receives: Procedure: 'Cutler-Beard modified with graft' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid retraction
Upper eyelid retraction in mm
Measured: 42 months
Secondary outcomes (4)
Retraction of the donor lower eyelid
Lower eyelid retraction in mm
Measured: 42 months
Lagophthalmos
Excessive aperture of the eyelids, in mm
Measured: 42 months
Lid margin stability
in mm
Measured: 42 months
Eyelid status
Number of complications, being 0 the best result
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProcedureStudies 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
- Model description
- Retrospective review of charts of the patients enrolled
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Mencía-Gutiérrez, MD, Study chair, Hospital Universitario 12 de Octubre, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712995
- Sponsor's protocol ID
- RUE-2018
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication of the results in a journal
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft
- ClinicalTrials.gov ID
- NCT03712995
- Acronym / sponsor ID
- RUE-2018
- Conditions
- Reconstructive Surgical Procedure
- Keywords
- Cutler-Beard, tarsoconjunctival graft, upper eyelid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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 study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid
Detailed description
A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.
Functional, cosmetic outcomes and postoperative complications were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective review of charts of the patients enrolled
| Arm | Type | Receives |
|---|---|---|
| Cutler-Beard modified with graft | Experimental | Procedure: 'Cutler-Beard modified with graft'Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Upper eyelid defect after tumor resection
Key exclusion criteria (1 listed)
- previous surgery
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 |
|---|---|---|
| 'Cutler-Beard modified with graft'Also: Modified Cutler-Beard technique with tarsoconjunctival graftA tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described. | Procedure or surgery | Cutler-Beard modified with graft |
Primary outcome
Eyelid retraction
Time frame: 42 months
Upper eyelid retraction in mm
4 secondary outcomes
Retraction of the donor lower eyelid
Time frame: 42 months
Lagophthalmos
Time frame: 42 months
Lid margin stability
Time frame: 42 months
Eyelid status
Time frame: 42 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 10 Dec 2018.
- Individual participant dataSharing planned: No. Publication of the results in a journal
Related trials for Reconstructive Surgical Procedure
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Not yet recruitingObservational study
NHLBI-Emory Advanced Cardiac CT Reconstruction
Structural Heart Disease
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.
Enrique Mencía-Gutiérrez, MD study chair
Hospital Universitario 12 de Octubre, Madrid, Spain
Questions about this trial
What is this clinical trial studying?
A study testing 'Cutler-Beard modified with graft' in people with Reconstructive Surgical Procedure, run by Hospital Universitario 12 de Octubre.
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 10 Dec 2018. 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 retraction (time frame: 42 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 10 Dec 2018.