Preoperative Silicone Ointment and Wound Healing

Launched by YALE UNIVERSITY · Jul 12, 2022

Keywords

ClinConnect Summary

This study is testing whether applying a silicone ointment to the skin before planned head-and-neck surgery helps wounds heal and reduces scarring. It’s a randomized, blinded trial (participants, care teams, and researchers don’t know who gets the real ointment or a placebo). After surgery, all participants will use silicone ointment. The study is at Yale New Haven Hospital in Connecticut, led by Dr. Yan Lee, and about 60 adults are invited to join. No results are available yet, and the study is expected to finish around February 2026.

Who can participate: adults 18 and older who are scheduled for nonemergency head/neck surgery for a benign (non-cancer) condition and can follow study rules and give informed consent. People who are currently using scar-therapy products, have a silicone allergy, have skin conditions near the planned incision, need a tracheostomy after surgery, have active cancer or prior radiation to the area, had previous surgery on the planned incision, are on chronic steroids or immunosuppressants, cannot consent, or are not fluent in English are not eligible. If you join, you’ll apply silicone ointment to the incision area twice daily for about 2–6 weeks before surgery, then continue using it after surgery. The researchers will assess scar healing and appearance at about 3 months and again at 12 months, using scales that measure both patient and clinician views of the scar, plus monitor hospital stay, discharge location, any readmissions or extra visits, and wound problems over the following year.

Gender

ALL

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