Preoperative Silicone Ointment and Wound Healing

Yale University

Status: Invitation-only

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

Treatments: Other: Preoperative placebo ointment; Device: Preoperative silicone ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05461157

2000033013_a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Preoperative silicone ointment

Experimental group

Description:

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.

Treatment:

Device: Preoperative silicone ointment

Preoperative placebo ointment

Placebo Comparator group

Description:

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.

Treatment:

Other: Preoperative placebo ointment