Preoperative Silicone Ointment and Wound Healing

NCT05461157 | Enrolling By Invitation FDA Device

• 1 other identifier: 2000033013_a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Wound healing; Surgical incision; Scar; Hypertrophic scar; Keloid; Silicone ointment

Outcome Measures

Primary Outcomes (4)

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

  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 months after surgery

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

  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.

  12 months after surgery

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

  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).

  3 months after surgery

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

  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).

  12 months after surgery

Secondary Outcomes (5)

• Length of hospital stay

  30 days after surgery

• Discharge location

  30 days after surgery

• Number of readmissions

  1 year after surgery

• Need for follow-up

  1 year after surgery

• Wound complications

  1 year after surgery

Study Arms (2)

Preoperative silicone ointment

EXPERIMENTAL

Participants will apply silicone ointment to the area where the surgical incision will be made, twice daily for 2-6 weeks prior to their scheduled surgery.

Device: Preoperative silicone ointment

Preoperative placebo ointment

PLACEBO COMPARATOR

Participants will apply placebo ointment to the area where the surgical incision will be made, twice daily for 2-6 weeks prior to their scheduled surgery.

Other: Preoperative placebo ointment

Interventions

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.

Also known as: Biodermis Scar Aid Silicone Stick

Preoperative silicone ointment

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.

Also known as: Lip balm

Preoperative placebo ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Biodermis: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.

  PMID: 24030657 BACKGROUND

• Tran B, Wu JJ, Ratner D, Han G. Topical Scar Treatment Products for Wounds: A Systematic Review. Dermatol Surg. 2020 Dec;46(12):1564-1571. doi: 10.1097/DSS.0000000000002712.

  PMID: 32932267 BACKGROUND

• Balci DD, Inandi T, Dogramaci CA, Celik E. DLQI scores in patients with keloids and hypertrophic scars: a prospective case control study. J Dtsch Dermatol Ges. 2009 Aug;7(8):688-92. doi: 10.1111/j.1610-0387.2009.07034.x. Epub 2009 Feb 18. English, German.

  PMID: 19243478 BACKGROUND

MeSH Terms

Conditions

Cicatrix; Cicatrix, Hypertrophic; Keloid; Surgical Wound

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Yan Lee, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either silicone ointment or placebo ointment prior to undergoing scheduled surgery. After surgery, all participants will use silicone ointment.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: November 14, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)