Silicone Ointment for Wound Healing

N/A

Waitlist Available

Led By Yan Lee, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Summary

This trial finds that preoperative silicone ointment is effective in wound healing following head and neck surgery.

Who is the study for?

This trial is for individuals scheduled for non-emergency head or neck surgery due to benign conditions, who can follow the study's procedures and have given informed consent. It excludes those on chronic steroids/immunosuppressants, with skin integrity issues like severe acne or psoriasis, allergies to silicone ointment components, active cancer at the surgical site, or need for post-surgery tracheostomy.

What is being tested?

The study tests if applying a silicone ointment before surgery can improve wound healing in patients undergoing head and neck surgeries. Participants will receive either the silicone ointment or a placebo without active ingredients before their procedure.

What are the potential side effects?

Potential side effects may include allergic reactions to the silicone ointment ingredients. However, since this is a topical treatment applied preoperatively, significant side effects are not commonly expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)

Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale

Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)

+1 more

Secondary study objectives

Discharge location

Length of hospital stay

Need for follow-up

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Preoperative silicone ointmentExperimental Treatment1 Intervention

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 II: Preoperative placebo ointmentPlacebo Group1 Intervention

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.

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