Clinical trial NCT05461157: Preoperative Silicone Ointment and Wound Healing
Official title: The Application of Preoperative Silicone Ointment and Its Effect on Wound Healing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Wound Heal
Scar
Scar, Hypertrophic
Keloid
Keloid Scar Following Surgery
Surgical Incision
Keywords: Wound healing
Surgical incision
Scar
Hypertrophic scar
Keloid
Silicone ointment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Biodermis
First posted: 2022-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 3 months after surgery
measure: Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 12 months after surgery
measure: Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
timeFrame: 3 months after surgery
measure: Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: Discharge location
timeFrame: 30 days after surgery
measure: Number of readmissions
timeFrame: 1 year after surgery
measure: Need for follow-up
timeFrame: 1 year after surgery
measure: Wound complications
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Yan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.