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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,608 Total Patients Enrolled

BiodermisUNKNOWN

Yan Lee, MDPrincipal InvestigatorYale School of Medicine

Media Library

Preoperative placebo ointment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05461157 — N/A

Wound Healing Research Study Groups: Preoperative placebo ointment, Preoperative silicone ointment

Wound Healing Clinical Trial 2023: Preoperative placebo ointment Highlights & Side Effects. Trial Name: NCT05461157 — N/A

Preoperative placebo ointment (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05461157 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities to join this clinical experimentation?

"The information hosted on clinicaltrials.gov suggests that this research project is no longer recruiting, as the last update was made on November 14th 2022. Despite this, there are currently 942 other trials actively seeking patients' participation."

Answered by AI

What are the intended results of this experiment?

"This clinical trial aims to quantify wound healing over a 12-month period by employing the Scar Cosmesis Assessment and Rating (SCAR) Scale. Secondary metrics such as readmissions, discharge location, and need for follow-up will be evaluated too."

Answered by AI