A Comparison of the Effect of Suture Material on Blepharoplasty Incision

• ClinicalTrials.gov Identifier: NCT04585217
• Recruitment Status: Recruiting
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Massachusetts Eye and Ear Infirmary
• Information provided by (Responsible Party): Michael Yoon, Massachusetts Eye and Ear Infirmary

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dermatochalasis; Ptosis, Eyelid	Procedure: Different suture materials for closure (6-0 polypropylene monofilament suture versus fast absorbing gut suture)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of the Effect of Suture Material on Blepharoplasty Incision
• Actual Study Start Date: May 30, 2020
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Plain gut suture; Plain gut suture closure of blepharoplasty incision	Procedure: Different suture materials for closure (6-0 polypropylene monofilament suture versus fast absorbing gut suture); 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. A randomized block design will be used to randomize eyelids to suture types. Blocks of 10 patients will be used. Each block will have 5 right eyelids with plain gut suture, 5 right eyelids with polypropylene suture, 5 left eyelids with plain gut suture, and 5 left eyelids with polypropylene suture.
Active Comparator: Polypropylene suture; Polypropylene suture closure of blepharoplasty incision	Procedure: Different suture materials for closure (6-0 polypropylene monofilament suture versus fast absorbing gut suture); 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. A randomized block design will be used to randomize eyelids to suture types. Blocks of 10 patients will be used. Each block will have 5 right eyelids with plain gut suture, 5 right eyelids with polypropylene suture, 5 left eyelids with plain gut suture, and 5 left eyelids with polypropylene suture.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Adverse outcomes per Fitzpatrick skin type [ Time Frame: 3 months ]
   Number and type of adverse outcomes stratified by Fitzpatrick skin type

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Victor Liou; 617 573 5529; victor_liou@meei.harvard.edu

Locations

United States, Massachusetts

Massachusetts Eye and Ear; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Victor Liou, MD

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

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

More Information

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.

Scaccia FJ, Hoffman JA, Stepnick DW. Upper eyelid blepharoplasty. A technical comparative analysis. Arch Otolaryngol Head Neck Surg. 1994 Aug;120(8):827-30.

• Responsible Party: Michael Yoon, Associate Professor, Oculoplastics, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT04585217
• Other Study ID Numbers: 2020P000543
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Yoon, Massachusetts Eye and Ear Infirmary:

Blepharoplasty; Dermatochalasis; Wound healing; Suture; Scar

Additional relevant MeSH terms:

Blepharoptosis; Cutis Laxa; Skin Diseases, Genetic; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Eyelid Diseases; Eye Diseases