NCT04585217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

October 5, 2020

Last Update Submit

October 20, 2023

Conditions

DermatochalasisPtosis, Eyelid

Keywords

BlepharoplastyDermatochalasisWound healingSutureScar

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse outcomes per Fitzpatrick skin type

    3 months

Study Arms (2)

Plain gut suture on right eyelid

ACTIVE COMPARATOR

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)

Polypropylene suture on right eyelid

ACTIVE COMPARATOR

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)

Interventions

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

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.

Plain gut suture on right eyelidPolypropylene suture on right eyelid

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 19797100BACKGROUND

  • 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.

    PMID: 8049043BACKGROUND

MeSH Terms

Conditions

Cutis LaxaBlepharoptosisCicatrix

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesEyelid DiseasesEye DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael K Yoon, MD

    Massachusetts Eye and Ear Infirmary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Oculoplastics

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 14, 2020

Study Start

May 30, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

US(1)