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NCT05461157

Preoperative Silicone Ointment and Wound Healing

Enrolling by Invitation
NAAges 18+InterventionalPrevention
Yale University
~60 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Preoperative silicone ointmentPreoperative placebo ointment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
Measured over 3 months after surgery
+3 more outcomes measured

Conditions

Wound Heal
Scar
Scar, Hypertrophic
Keloid
Keloid Scar Following Surgery
Surgical Incision

Explore related trials

Hypertrophic ScarKeloidScarSurgical IncisionWound healed

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Yan Lee, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Scheduled to undergo non-emergent surgery of the head and/or neck for a benign (non-cancerous) condition
Able to comply with all study procedures for the duration of the study
Provision of signed and dated informed consent form

Exclusion

Current use of products intended to improve scar healing (silicone or otherwise); skincare products not specifically marketed for scar healing are acceptable
Known allergic reactions to components of the silicone ointment
Dermatologic conditions that disrupt the integrity of the skin, e.g. severe acne, psoriasis
Need for tracheostomy postoperatively
Have any form of active malignancy at the time of surgery
Have a history of radiation involving the surgical site
Prior surgery involving all or part of the planned surgical incision
Current use of chronic steroids or other immunosuppressive medications
Lack of decision-making capacity
Not fluent in English

What this trial measures

  • Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)3 months after surgery

    The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.

  • Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)12 months after surgery

    The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.

  • Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale3 months after surgery

    The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).

  • Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale12 months after surgery

    The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).