Lower Eyelid EntropionNCT01598376
A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
A study testing 7/0 vicryl suture and 5/0 vicryl test suture in people with Lower Eyelid Entropion, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
Objective To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response. Design A prospective, double blind, randomized clinical trial using a novel ethical study design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Eyelid Entropion
- What is being tested?
- 7/0 vicryl suture and 5/0 vicryl test suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients
- Involutional lower eyelid entropion
- Horizontal eyelid laxity associated
- Informed consent
Who cannot join
- Inability to provide informed consent
- Previous eyelid surgery
- Poorly controlled diabetes
- Oral steroid use
- Addisons disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Objective
To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response.
Read more
Design
A prospective, double blind, randomized clinical trial using a novel ethical study design. Both the patient and clinician analyzing the histology were blinded to the suture gauge used.
Participants
A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study.
Intervention
Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. After 28 days, entropion correction was achieved by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture.
Main outcome measure
Defined histological parameters of suture-related granulomas were measured at multiple levels. Data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.
- Conditions
- Lower Eyelid Entropion
- Being tested
- 7/0 vicryl suture, 5/0 vicryl test suture
- Keywords
- entropion, suture, granuloma, tissue reaction
- Medical subject headings
- Entropion, Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7/0 vicryl sutureProcedure or surgery
7/0 vicryl test suture placed as one of 3 everting sutures
5/0 vicryl test sutureProcedure or surgery
5/0 vicryl test suture placed as one of 3 everting sutures
| Study group | Role | What they receive |
|---|---|---|
| 5/0 gauge vicryl suture | Active comparator | Patients randomly assigned to 5/0 gauge test everting suture Receives: Procedure: 5/0 vicryl test suture |
| 7/0 gauge vicryl suture | Active comparator | Patients randomly assigned to 7/0 gauge test everting suture Receives: Procedure: 7/0 vicryl suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suture associated granuloma outer diameter
Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
Measured: 28 days
Suture associated granuloma central cellular element diameter
Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined
Measured: 28 days
Suture associated granuloma fibrous coat area
Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
Measured: 28 days
Suture associated granuloma giant cell number
Count of giant cells on average of 6 histological sections from excised eyelid specimens
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Eyelid EntropionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Parkin, The Royal Bournemouth Hospital
- Investigators
- Ben Parkin, MD, Principal investigator, Royal Bournemouth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598376
- Sponsor's protocol ID
- RBH Suture Study
- Status last verified
- May 2012
- First submitted
- 11 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
- ClinicalTrials.gov ID
- NCT01598376
- Acronym / sponsor ID
- RBH Suture Study
- Conditions
- Lower Eyelid Entropion
- Keywords
- entropion, suture, granuloma, tissue reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 May 2012 (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.
Objective
To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response.
Design
A prospective, double blind, randomized clinical trial using a novel ethical study design. Both the patient and clinician analyzing the histology were blinded to the suture gauge used.
Participants
A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study.
Intervention
Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. After 28 days, entropion correction was achieved by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture.
Main outcome measure
Defined histological parameters of suture-related granulomas were measured at multiple levels. Data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5/0 gauge vicryl suture | Active comparator | Procedure: 5/0 vicryl test suturePatients randomly assigned to 5/0 gauge test everting suture |
| 7/0 gauge vicryl suture | Active comparator | Procedure: 7/0 vicryl suturePatients randomly assigned to 7/0 gauge test everting suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consecutive patients
- Involutional lower eyelid entropion
- Horizontal eyelid laxity associated
- Informed consent
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Previous eyelid surgery
- Poorly controlled diabetes
- Oral steroid use
- Addisons disease
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 |
|---|---|---|
| 7/0 vicryl suture7/0 vicryl test suture placed as one of 3 everting sutures | Procedure or surgery | 7/0 gauge vicryl suture |
| 5/0 vicryl test suture5/0 vicryl test suture placed as one of 3 everting sutures | Procedure or surgery | 5/0 gauge vicryl suture |
Primary outcome
Suture associated granuloma outer diameter
Time frame: 28 days
Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma central cellular element diameter
Time frame: 28 days
Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma fibrous coat area
Time frame: 28 days
Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma giant cell number
Time frame: 28 days
Count of giant cells on average of 6 histological sections from excised eyelid specimens
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 15 May 2012.
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.
Ben Parkin, MD principal investigator
Royal Bournemouth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7/0 vicryl suture and 5/0 vicryl test suture in people with Lower Eyelid Entropion, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 15 May 2012. 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 Kingdom. 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 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?
Suture associated granuloma outer diameter (time frame: 28 days). The study lists 4 primary outcomes in all. 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 15 May 2012.