Preoperative Silicone Ointment and Wound Healing

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: 3 months after surgery]
• Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: 12 months after surgery]
• Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale [Срок оценки: 3 months after surgery]
• Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale [Срок оценки: 12 months after surgery]

Вторичные конечные точки (5)

• Length of hospital stay [Срок оценки: 30 days after surgery]
• Discharge location [Срок оценки: 30 days after surgery]
• Number of readmissions [Срок оценки: 1 year after surgery]
• Need for follow-up [Срок оценки: 1 year after surgery]
• Wound complications [Срок оценки: 1 year after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Yale New Haven Hospital — New Haven

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT05461157 · 2000033013_a

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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