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Preoperative Silicone Ointment and Wound Healing

NCT05461157 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Wound Heal
  • Scar
  • Scar, Hypertrophic
  • Keloid
  • Keloid Scar Following Surgery
  • Surgical Incision

Interventions

DEVICE

Preoperative silicone ointment

The silicone ointment in this study is the Biodermis Scar Aid Silicone Stick, an FDA-approved silicone ointment that is available for purchase over the counter.

OTHER

Preoperative placebo ointment

The placebo ointment in this study is a generic, non-flavored lip balm that is identical in packaging and texture to the Biodermis Scar Aid Silicone Stick used in the treatment arm.

Sponsors & Collaborators

  • Biodermis

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Yan Lee, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2026-10-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461157 on ClinicalTrials.gov