Silicone Ointment for Wound Healing

Overseen By Yan Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Chronic steroids

Disqualifiers: Active malignancy, Radiation history, others

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using any products specifically intended to improve scar healing, but regular skincare products are fine. If you are on chronic steroids or other immunosuppressive medications, you cannot participate in the trial.

How does the silicone ointment treatment for wound healing differ from other treatments?

The silicone ointment treatment is unique because it uses silicone, which has been shown to promote faster wound healing and prevent scarring by forming a protective barrier over the skin. This is different from other treatments that may not specifically target scar prevention or use silicone's film-forming properties. ^{1 2 3 4 5}

Research Team

Yan Lee, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

Provision of signed and dated informed consent form

I am scheduled for a non-urgent head or neck surgery for a non-cancerous condition.

Able to comply with all study procedures for the duration of the study

Exclusion Criteria

I have had radiation therapy on the area where I will have surgery.

I have an active cancer at the time of my surgery.

I am currently taking steroids or other medications that weaken my immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants apply silicone or placebo ointment to the surgical site twice daily for 2-6 weeks prior to surgery

2-6 weeks

Surgery

Participants undergo the scheduled surgical procedure

Short-term Follow-up

Short-term wound healing is assessed using the SCAR and POSAS scales

3 months

Long-term Follow-up

Long-term wound healing is assessed using the SCAR and POSAS scales, and other outcomes like readmissions and wound complications are monitored

12 months

Treatment Details

Interventions

• Preoperative placebo ointment
• Preoperative silicone ointment

Trial Overview 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.

Participant Groups

Group I: Preoperative silicone ointment Experimental Treatment 1 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 ointment Placebo Group 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Biodermis

Collaborator

Trials

1

Recruited

60+

References

1. United States pubmed.ncbi.nlm.nih.gov

The safety, efficacy, and tolerability of a novel silicone gel dressing following dermatological surgery. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

The Use of Silgel STC-SE, a Topical Silicone Gel for the Treatment and Reduction of Hypertrophic and Keloid Scars. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of topical silicone gel in scar management: A systematic review and meta-analysis of randomised controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Silicone-Based Scar Cream for Post Upper Eyelid Blepharoplasty-associated Cicatricial and Hypertrophic Scarring [2019]

5. England pubmed.ncbi.nlm.nih.gov

The use of silicone gel in the treatment of fresh surgical scars: a randomized study. [2009]