Preoperative Silicone Ointment and Wound Healing

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05461157
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative silicone ointment — DEVICE
    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.
  • Preoperative placebo ointment — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 14, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Preoperative silicone ointment
    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.
  • Placebo Comparator: Preoperative placebo ointment
    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.

Primary Outcome Measure

Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 3 months after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510-

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Yale New Haven Hospital· New Haven, CT

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