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Enrolling by Invitation

NCT Number: NCT05461157

Preoperative Silicone Ointment and Wound Healing

Optimal scar healing is of great importance to patients, especially following surgery of the head and neck. This study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

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Key information

Conditions

Wound Heal Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Keloid Keloid Scar Following Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Scar, Hypertrophic Skin and Connective Tissue Diseases Surgical Incision Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

Following surgical procedures, the formation of hypertrophic scars and keloids affects patients' well-being, including quality of life and mental/psychological health. Scars in certain areas, including the face, neck, ears, and upper chest and back, are especially likely to develop abnormally. Due to these adverse outcomes, patients often request products and procedures that will improve the appearance of scars. Few studies have addressed preoperative measures that can improve scar healing.

Surgeons often recommend that patients apply moisturizing ointments to the area of the incision prior to surgery; however, this is based on clinical consensus and is not evidence-based. Silicone products are understood to promote hydration of the skin and are considered first-line prophylactic and treatment therapy for abnormal scars (hypertrophic scars and keloids) when used after a surgery or injury. This study seeks to evaluate preoperative application of silicone ointment and its effect on surgical scar healing.

The success of surgical scar healing will be determined by researcher and participant ratings on validated scar assessment scales. The secondary objective of this study is to evaluate the effect of preoperative application of silicone ointment on postoperative wound complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Preoperative silicone ointment

Device

The silicone ointment in this study is the Biodermis Scar Aid Silicone Stick, an FDA-approved silicone ointment that is available for purchase over the counter.

Other names: Biodermis Scar Aid Silicone Stick

Preoperative placebo ointment

Other

The placebo ointment in this study is a generic, non-flavored lip balm that is identical in packaging and texture to the Biodermis Scar Aid Silicone Stick used in the treatment arm.

Other names: Lip balm

Primary outcomes

  1. Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 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.

  2. Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 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.

  3. Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale

    Time frame: 3 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).

  4. Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale

    Time frame: 12 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).

Secondary outcomes

  1. Length of hospital stay

    Time frame: 30 days after surgery

    Number of days a participant stays in the hospital following their scheduled surgery

  2. Discharge location

    Time frame: 30 days after surgery

    Location (e.g. home, skilled nursing facility, etc.) to which a participant is discharged following surgery

  3. Number of readmissions

    Time frame: 1 year after surgery

    Number of times a participant is readmitted to the hospital

  4. Need for follow-up

    Time frame: 1 year after surgery

    Number of clinic or emergency department (ED) visits that are not part of the participant's routine care

  5. Wound complications

    Time frame: 1 year after surgery

    Whether the participant had unexpected complications including infection, excessive bleeding, or dehiscence

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Biodermis

Registry information

Official study title

The Application of Preoperative Silicone Ointment and Its Effect on Wound Healing

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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