A Comparison of the Effect of Suture Material on Blepharoplasty Incision
Condition: Dermatochalasis; Ptosis, Eyelid
MeSH terms: Blepharoptosis; Cutis Laxa
Study type: Interventional

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.
    

Intervention name(s): Randomized laterality of suture materials for closure (6-0 polypropylene monofilament suture vs fast absorbing gut suture on right eyelid)
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blepharoplasty; Dermatochalasis; Wound healing; Suture; Scar