Preoperative Silicone Ointment and Wound Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Preoperative silicone ointment

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.

Group Type EXPERIMENTAL

Preoperative silicone ointment

Intervention Type 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.

Preoperative placebo ointment

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.

Group Type PLACEBO_COMPARATOR

Preoperative placebo ointment

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Biodermis Scar Aid Silicone Stick Lip balm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No