Preoperative Silicone Ointment and Wound Healing

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05461157
• Other study ID #: IRB# 2000033013
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophy
• Keloid
• Keloid Scar Following Surgery
• Scar
• Surgical Incision
• Surgical Wound
• Wound Heal
• Wounds and Injuries

Intervention

Device:
• Preoperative silicone ointment
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:
• Preoperative placebo ointment
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Biodermis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Length of hospital stay	Number of days a participant stays in the hospital following their scheduled surgery	30 days after surgery
Secondary	Discharge location	Location (e.g. home, skilled nursing facility, etc.) to which a participant is discharged following surgery	30 days after surgery
Secondary	Number of readmissions	Number of times a participant is readmitted to the hospital	1 year after surgery
Secondary	Need for follow-up	Number of clinic or emergency department (ED) visits that are not part of the participant's routine care	1 year after surgery
Secondary	Wound complications	Whether the participant had unexpected complications including infection, excessive bleeding, or dehiscence	1 year after surgery