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Clinical Trials/NCT04585217
NCT04585217CompletedNot Applicable

A Comparison of the Effect of Suture Material on Blepharoplasty Incision

Massachusetts Eye and Ear Infirmary1 site in 1 country23 target enrollmentStarted: May 30, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Patient Observer Scar Assessment Scale

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients 18-89 years old
  • •Patients who qualify for functional blepharoplasty

Exclusion Criteria

  • •Patients <18 or >89 years old
  • •Previous eyelid surgery
  • •History of connective tissue disease
  • •Mental handicap
  • •Pregnant women
  • •Incarcerated persons

Arms & Interventions

Plain gut suture on right eyelid

Active Comparator

Plain gut suture closure of blepharoplasty incision

Intervention: Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid) (Procedure)

Polypropylene suture on right eyelid

Active Comparator

Polypropylene suture closure of blepharoplasty incision

Intervention: Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid) (Procedure)

Outcomes

Primary Outcomes

Patient Observer Scar Assessment Scale

Time Frame: 3 months

This validated scale has the patient and observer grade their scar on different components. The observer rates on vascularity, pigmentation, thickness, relief, pliability, surface area, and overall opinion. This is done on a 1 - 10 scale with 1 being completely normal skin and 10 being the worst scar imaginable. The patient rates the scar based on pain, itching, color, stiffness, thickness, irregularity, and overall opinion. This is graded on a 1 - 10 scale with 1 being No (absolutely not) and 10 being Yes (absolutely yes). The outcome is a difference of \> or = 3-points.

Secondary Outcomes

  • Adverse outcomes per Fitzpatrick skin type(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Yoon

Associate Professor, Oculoplastics

Massachusetts Eye and Ear Infirmary

Study Sites (1)

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