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By invitation only Not applicable NCT05461157

Preoperative Silicone Ointment and Wound Healing

No applicable phase (e.g. observational)
Conditions: Wound Heal Scar Scar, Hypertrophic Keloid Keloid Scar Following Surgery Surgical Incision

Sponsor: Yale University

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Preoperative silicone ointment
DEVICE
Preoperative placebo ointment
OTHER
Locations 1
United States (1)
Yale New Haven Hospital
New Haven , Connecticut
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.11.2022
Completion date
01.07.2027
Registry ID
NCT05461157
Source
clinicaltrials.gov
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