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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
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 moreSecondary study objectives
Discharge location
Length of hospital stay
Need for follow-up
+2 moreTrial 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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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,672 Total Patients Enrolled
BiodermisUNKNOWN
Yan Lee, MDPrincipal InvestigatorYale School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am unable to make my own health care decisions.I am not fluent in English.I am scheduled for a non-urgent head or neck surgery for a non-cancerous condition.I will need a tracheostomy after surgery.I have severe skin conditions like bad acne or psoriasis.I am using products designed to improve scar healing.
Research Study Groups:
This trial has the following groups:- Group 1: Preoperative placebo ointment
- Group 2: Preoperative silicone ointment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.