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Preoperative Silicone Ointment and Wound Healing

Primary Purpose

Wound Heal, Scar, Scar, Hypertrophic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative silicone ointment
Preoperative placebo ointment
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Heal focused on measuring Wound healing, Surgical incision, Scar, Hypertrophic scar, Keloid, Silicone ointment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo non-emergent surgery of the head and/or neck for a benign (non-cancerous) condition
  • Able to comply with all study procedures for the duration of the study
  • Provision of signed and dated informed consent form

Exclusion Criteria:

  • Current use of products intended to improve scar healing (silicone or otherwise); skincare products not specifically marketed for scar healing are acceptable
  • Known allergic reactions to components of the silicone ointment
  • Dermatologic conditions that disrupt the integrity of the skin, e.g. severe acne, psoriasis
  • Need for tracheostomy postoperatively
  • Have any form of active malignancy at the time of surgery
  • Have a history of radiation involving the surgical site
  • Current use of chronic steroids or other immunosuppressive medications
  • Lack of decision-making capacity
  • Not fluent in English

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preoperative silicone ointment

Preoperative placebo ointment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.
Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.
Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).
Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).

Secondary Outcome Measures

Length of hospital stay
Number of days a participant stays in the hospital following their scheduled surgery
Discharge location
Location (e.g. home, skilled nursing facility, etc.) to which a participant is discharged following surgery
Number of readmissions
Number of times a participant is readmitted to the hospital
Need for follow-up
Number of clinic or emergency department (ED) visits that are not part of the participant's routine care
Wound complications
Whether the participant had unexpected complications including infection, excessive bleeding, or dehiscence

Full Information

First Posted
July 6, 2022
Last Updated
June 2, 2023
Sponsor
Yale University
Collaborators
Biodermis
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1. Study Identification

Unique Protocol Identification Number
NCT05461157
Brief Title
Preoperative Silicone Ointment and Wound Healing
Official Title
The Application of Preoperative Silicone Ointment and Its Effect on Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Biodermis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
Detailed Description
Following surgical procedures, the formation of hypertrophic scars and keloids affects patients' well-being, including quality of life and mental/psychological health. Scars in certain areas, including the face, neck, ears, and upper chest and back, are especially likely to develop abnormally. Due to these adverse outcomes, patients often request products and procedures that will improve the appearance of scars. Few studies have addressed preoperative measures that can improve scar healing. Surgeons often recommend that patients apply moisturizing ointments to the area of the incision prior to surgery; however, this is based on clinical consensus and is not evidence-based. Silicone products are understood to promote hydration of the skin and are considered first-line prophylactic and treatment therapy for abnormal scars (hypertrophic scars and keloids) when used after a surgery or injury. This study seeks to evaluate preoperative application of silicone ointment and its effect on surgical scar healing. The success of surgical scar healing will be determined by researcher and participant ratings on validated scar assessment scales. The secondary objective of this study is to evaluate the effect of preoperative application of silicone ointment on postoperative wound complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Scar, Scar, Hypertrophic, Keloid, Keloid Scar Following Surgery, Surgical Incision
Keywords
Wound healing, Surgical incision, Scar, Hypertrophic scar, Keloid, Silicone ointment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either silicone ointment or placebo ointment prior to undergoing scheduled surgery. After surgery, all participants will use silicone ointment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative silicone ointment
Arm Type
Experimental
Arm Description
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.
Arm Title
Preoperative placebo ointment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Preoperative silicone ointment
Other Intervention Name(s)
Biodermis Scar Aid Silicone Stick
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Preoperative placebo ointment
Other Intervention Name(s)
Lip balm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
Description
The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.
Time Frame
3 months after surgery
Title
Long-term wound healing measured by the Patient and Observer Scar Assessment Scale (POSAS)
Description
The Patient and Observer Scar Assessment Scale (POSAS) includes two components: an observer's evaluation of a scar and a patient's evaluation of a scar. The Patient Scar Assessment Scale component asks the patient the degree to which the scar is painful or itchy, how the color, stiffness, thickness, and irregularity of the scar compare to the patient's normal skin, and the patient's overall opinion of the scar. Each question is scored on a scale of 1 (not at all painful, itchy, or different) to 10 (very much painful, itchy, or different), and the numbers are totaled to produce a final score. The Observer Scar Assessment Scale component measures vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as the observer's overall opinion of the scar. Each question is scored on a scale of 1 (like normal skin) to 10 (worst scar imaginable), and the numbers are totaled to produce a final score.
Time Frame
12 months after surgery
Title
Short-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
Description
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).
Time Frame
3 months after surgery
Title
Long-term wound healing measured by the Scar Cosmesis Assessment and Rating (SCAR) Scale
Description
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated measure consisting of both observer and patient evaluations. The observer assesses scar spread, erythema, dyspigmentation, suture marks, hypertrophy or atrophy, and overall impression. The patient reports whether the scar is itchy or painful. The SCAR scale can be used to assess scars in person or photos of scars. The total possible score ranges from 0 (best possible scar) to 15 (worst possible scar).
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Number of days a participant stays in the hospital following their scheduled surgery
Time Frame
30 days after surgery
Title
Discharge location
Description
Location (e.g. home, skilled nursing facility, etc.) to which a participant is discharged following surgery
Time Frame
30 days after surgery
Title
Number of readmissions
Description
Number of times a participant is readmitted to the hospital
Time Frame
1 year after surgery
Title
Need for follow-up
Description
Number of clinic or emergency department (ED) visits that are not part of the participant's routine care
Time Frame
1 year after surgery
Title
Wound complications
Description
Whether the participant had unexpected complications including infection, excessive bleeding, or dehiscence
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo non-emergent surgery of the head and/or neck for a benign (non-cancerous) condition Able to comply with all study procedures for the duration of the study Provision of signed and dated informed consent form Exclusion Criteria: Current use of products intended to improve scar healing (silicone or otherwise); skincare products not specifically marketed for scar healing are acceptable Known allergic reactions to components of the silicone ointment Dermatologic conditions that disrupt the integrity of the skin, e.g. severe acne, psoriasis Need for tracheostomy postoperatively Have any form of active malignancy at the time of surgery Have a history of radiation involving the surgical site Current use of chronic steroids or other immunosuppressive medications Lack of decision-making capacity Not fluent in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Lee, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24030657
Citation
O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
Results Reference
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PubMed Identifier
32932267
Citation
Tran B, Wu JJ, Ratner D, Han G. Topical Scar Treatment Products for Wounds: A Systematic Review. Dermatol Surg. 2020 Dec;46(12):1564-1571. doi: 10.1097/DSS.0000000000002712.
Results Reference
background
PubMed Identifier
19243478
Citation
Balci DD, Inandi T, Dogramaci CA, Celik E. DLQI scores in patients with keloids and hypertrophic scars: a prospective case control study. J Dtsch Dermatol Ges. 2009 Aug;7(8):688-92. doi: 10.1111/j.1610-0387.2009.07034.x. Epub 2009 Feb 18. English, German.
Results Reference
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Preoperative Silicone Ointment and Wound Healing

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