A Comparison of the Effect of Suture Material on Blepharoplasty Incision

Status Completed

Clinical Trial Summary

The objective is to compare the effect of suture material on blepharoplasty incision. Outcomes of blepharoplasty scar and/or cosmesis will be compared between plain gut and polypropylene suture. Additionally, the study will assess whether certain Fitzpatrick skin types are associated with increased rates of poor outcomes after blepharoplasty.

Clinical Trial Description

Upper eyelid blepharoplasty is commonly performed surgical procedure. The procedure involves excising excess eyelid skin (sometimes with associated orbicularis oculi muscle and orbital fat). It generally has low risk with high success rate. Although blepharoplasty is usually performed for functional reasons, it can also be performed for purely cosmetic indications. Regardless the indication, patients still expect optimal cosmetic results. Various marking and surgical techniques have been described to maximize functional and aesthetic outcomes. However, there are lacking studies on the optimal suture material for upper blepharoplasty. A comprehensive review of the literature reveals three studies which discuss blepharoplasty outcomes related to suture material. The outcomes of all these studies were heavily influenced by subjective interpretation. Skin incisions can be closed with adhesives, sutures, staples, or allowed to secondarily granulate. There are many published reports on suture reaction and post-operative results on the face, body, and extremities. However, the eyelid skin is unique - it is the thinnest in the body. Post-operative edema, erythema, cyst and scar formation can have an effect on the cosmetic outcome. Sutures are the most common method used for closure in this setting. Types of sutures used in clinical practice include absorbable gut and polyglactin and non-absorbable polypropylene, nylon, and polyester. Sutures are most commonly placed as either a continuous running or subcuticular passes with and without reinforcing interrupted sutures. Anecdotally, suture-related complications have been observed in specific racial skin types as well as with various suture materials. Results of this study could lead to a more patient specific blepharoplasty with better and more predictable outcomes therefore improving patient care. Patients in the outpatient oculoplastics clinic will be evaluated for dermatochalasis and approved for upper blepharoplasty. Enrollment and consent into the study will be performed by the study coordinator. The purpose of the study, risks, benefits, and alternatives will be explained to the patient. If the patient is interested, he or she will be asked to sign a consent form for both the blepharoplasty procedure and the study. On the day of the procedure, the patient's eyelids and sutures will be randomized. The procedure on each eyelid will performed by the same surgeon. Patients will have the standard post-operative appointments at 1 week and 3 months. A survey will be given to patients to assess their blepharoplasty scar at each appointment. Deidentified photographs will also be taken of the patients and blindly assessed by the study investigators using an observer scar assessment scale. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04585217
Study type	Interventional
Source	Massachusetts Eye and Ear Infirmary
Contact
Status	Completed
Phase	N/A
Start date	May 30, 2020
Completion date	June 30, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05480098` - Brimonidine for Intraoperative Hemostasis	Phase 4
Recruiting	`NCT05890027` - Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation	Phase 4
Completed	`NCT06047418` - Blepharoptosis in Indonesia: A 5-Year Multicenter Study on Characteristics and Surgical Evaluation
Completed	`NCT04831047` - The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance	Phase 4
Active, not recruiting	`NCT04678115` - Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis	N/A
Not yet recruiting	`NCT04235803` - Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery	N/A
Completed	`NCT05770973` - Effect of Eyelid Patching After Ptosis Surgery	N/A
Completed	`NCT00753831` - Efficacy of Aurosling in Frontalis Sling Suspension Surgery	Phase 4
Completed	`NCT04291625` - Evaluation of Intraoperative Lagophthalmos Formula	N/A
Enrolling by invitation	`NCT03916107` - Comparison of Different Surgical Treatments for Severe Ptosis Correction	N/A
Completed	`NCT03818204` - Clinical Trial to Improve the Magnetic Levator Prosthesis	N/A
Recruiting	`NCT05750251` - Effect of Upper Eyelid Surgeries on Corneal Characteristics
Not yet recruiting	`NCT03392272` - Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue	N/A
Recruiting	`NCT01616108` - Bupivacaine Injection of Eye Muscles to Treat Strabismus	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.