A Comparison of the Effect of Suture Material on Blepharoplasty Incision

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.

Study Overview

• Status: Completed
• Conditions: Ptosis, Eyelid; Dermatochalasis
• Intervention / Treatment: Procedure: Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid)

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.

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor Liou; Phone Number: 617 573 5529; Email: victor_liou@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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
• Children
• Mental handicap
• Pregnant women
• Incarcerated persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plain gut suture on right eyelid; Plain gut suture closure of blepharoplasty incision	Procedure: Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid); Plain gut suture (6-0 fast absorbing plain gut [Sharpoint "Express gut" TM]) and polypropylene suture (6-0 polypropylene [Ethicon Prolene TM]) will be used to close blepharoplasty incisions. Each patient will have one eyelid using plain gut suture and the other eyelid with polypropylene suture. Each subject will be randomized as to laterality.
Active Comparator: Polypropylene suture on right eyelid; Polypropylene suture closure of blepharoplasty incision	Procedure: Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid); Plain gut suture (6-0 fast absorbing plain gut [Sharpoint "Express gut" TM]) and polypropylene suture (6-0 polypropylene [Ethicon Prolene TM]) will be used to close blepharoplasty incisions. Each patient will have one eyelid using plain gut suture and the other eyelid with polypropylene suture. Each subject will be randomized as to laterality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Observer Scar Assessment Scale	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse outcomes per Fitzpatrick skin type	Number and type of adverse outcomes stratified by Fitzpatrick skin type	3 months

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Michael K Yoon, MD, Massachusetts Eye and Ear Infirmary

Publications and helpful links

General Publications

• Jaggi R, Hart R, Taylor SM. Absorbable suture compared with nonabsorbable suture in upper eyelid blepharoplasty closure. Arch Facial Plast Surg. 2009 Sep-Oct;11(5):349-52. doi: 10.1001/archfacial.2009.53. No abstract available.
• Scaccia FJ, Hoffman JA, Stepnick DW. Upper eyelid blepharoplasty. A technical comparative analysis. Arch Otolaryngol Head Neck Surg. 1994 Aug;120(8):827-30. doi: 10.1001/archotol.1994.01880320029007.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Wound healing; Suture; Scar; Blepharoplasty; Dermatochalasis
• Additional Relevant MeSH Terms: Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Eyelid Diseases; Cutis Laxa; Blepharoptosis
• Other Study ID Numbers: 2020P000543

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No