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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether silicone ointment improves wound healing after head or neck surgery. Participants will apply either a preoperative silicone ointment or a placebo (a harmless, non-active ointment) to their skin before surgery to determine which is more effective for scar healing. It suits individuals planning non-emergency head or neck surgery for non-cancerous conditions and not currently using scar treatments.

As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially enhance future surgical outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that silicone ointment is generally safe for treating scars. One study found that applying a silicone scar gel twice daily improved the appearance of scars after three months, with no adverse side effects reported. Another source indicates that silicone-based products for scars are usually safe, with only minor side effects such as itching or rash. These findings suggest that silicone ointment is well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional wound healing treatments that often rely on topical antibiotics or dressings, silicone ointment is gaining attention for its potential to enhance healing through a different approach. Silicone ointments create a protective barrier over the wound, which helps retain moisture and supports the skin's natural healing process. Researchers are excited about this because it could lead to reduced scarring and faster recovery times without the drawbacks of antibiotic resistance. This novel use of silicone could offer a safer and more effective alternative for preoperative wound care.

What evidence suggests that preoperative silicone ointment is effective for wound healing?

Research shows that silicone ointment effectively manages scars. In this trial, participants will receive either a preoperative silicone ointment or a placebo ointment. Studies have found that silicone gel significantly reduces the color, size, and hardness of scars after surgery compared to placebo or no treatment. Additionally, scars treated with silicone appeared better just six weeks after starting treatment. Early use of silicone gel also aids in effective scar management. These findings suggest that silicone ointment may enhance healing and improve scar appearance, particularly for surgeries on the head and neck. ^{2 4 6 7 8}

Who Is on the Research Team?

Yan Lee, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949016/

Efficacy of topical silicone gel in scar management Topical silicone gel significantly reduced pigmentation, height, and pliability scores postoperatively compared with placebos or no treatment.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK586090/

Silicone Gel for Scar Prevention - NCBI - NIH This chapter highlights the original findings, evidence, and working mechanism of silicone gel for scar prevention and management.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05461157

Preoperative Silicone Ointment and Wound Healing This study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0305417924001050

A randomised investigation of film-forming silicone gel in ... Silicone treated wounds were associated with a significant improvement in scar pigmentation outcome at six weeks post-burn.

5. jcadonline.com jcadonline.com/efficacy-and-safety-of-a-novel-100-silicone-scar-gel-treatment-for-early-intervention-in-scar-management/

Efficacy and Safety of a Novel 100% Silicone Scar Gel ... Still, the encouraging results of the present study support the use of this novel 100% silicone gel in the early intervention for the management of scars.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5300722/

Efficacy and Safety of a Novel 100% Silicone Scar Gel ... The test product improved the appearance of scars after three months of twice-daily treatment and without adverse events.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4486716/

The Use of Silicone Adhesives for Scar Reduction - PMC First aid products using silicone gel could improve the outcome of scarring following accidents in the home as well as providing protection to newly healed ...

8. news-medical.net news-medical.net/health/The-Science-Behind-Silicone-Scar-Tape.aspx

The Science Behind Silicone Scar Tape Silicone scar tape is generally safe and is associated with minimal side effects, some of which may include itching, rash, breakdown of skin ...