A Comparison of the Effect of Suture Material on Blepharoplasty Incision
Primary Purpose
Dermatochalasis, Ptosis, Eyelid
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid)
Sponsored by
About this trial
This is an interventional treatment trial for Dermatochalasis focused on measuring Blepharoplasty, Dermatochalasis, Wound healing, Suture, Scar
Eligibility 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
Sites / Locations
- Massachusetts Eye and Ear
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Plain gut suture on right eyelid
Polypropylene suture on right eyelid
Arm Description
Plain gut suture closure of blepharoplasty incision
Polypropylene suture closure of blepharoplasty incision
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse outcomes per Fitzpatrick skin type
Number and type of adverse outcomes stratified by Fitzpatrick skin type
Full Information
NCT ID
NCT04585217
First Posted
October 5, 2020
Last Updated
October 20, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT04585217
Brief Title
A Comparison of the Effect of Suture Material on Blepharoplasty Incision
Official Title
A Comparison of the Effect of Suture Material on Blepharoplasty Incision
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatochalasis, Ptosis, Eyelid
Keywords
Blepharoplasty, Dermatochalasis, Wound healing, Suture, Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plain gut suture on right eyelid
Arm Type
Active Comparator
Arm Description
Plain gut suture closure of blepharoplasty incision
Arm Title
Polypropylene suture on right eyelid
Arm Type
Active Comparator
Arm Description
Polypropylene suture closure of blepharoplasty incision
Intervention Type
Procedure
Intervention Name(s)
Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Observer Scar Assessment Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse outcomes per Fitzpatrick skin type
Description
Number and type of adverse outcomes stratified by Fitzpatrick skin type
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Yoon, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19797100
Citation
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.
Results Reference
background
PubMed Identifier
8049043
Citation
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.
Results Reference
background
Learn more about this trial
A Comparison of the Effect of Suture Material on Blepharoplasty Incision
We'll reach out to this number within 24 hrs