Back to resultsScar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
Primary Purpose
Scar, Skin Scarring, Skin Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrocolloid dressing
Petrolatum jelly dressing
Sponsored by
About this trial
This is an interventional treatment trial for Scar focused on measuring scar, dermatologic surgery, wound healing, wound of skin, skin cancer, surgical incision, patient satisfaction, patient preference, cosmetic outcome, scar appearance
Eligibility Criteria
Inclusion Criteria: Adult > 18 years of age Linear scars Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention Exclusion Criteria: Scar localization on acral or hair bearing sites Patients unable to converse in English Patients requiring flap or graft for closure of wound History of allergy to adhesives Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery Use of hydrocolloid dressings for post-operative wound care in the past
Sites / Locations
- IU Health Physicians Dermatology Meridian CrossingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hydrocolloid dressing arm
Petrolatum jelly dressing arm
Arm Description
After informed consent and closing the wound with the sutures, the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days (Experimental)
and the other group of patients (control), after closing the wound with the sutures, the scar will be covered with petrolatum jelly during this time period, which has to be re-applied daily.
Outcomes
Primary Outcome Measures
Cosmetic outcome
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Cosmetic outcome
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Cosmetic outcome
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Secondary Outcome Measures
Complication rate
Complication rate including hematoma, seroma, wound infection requiring antibiotics, opening and drainage of wound, dehiscence. Complications will be assessed by physicians other than operating surgeon
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05618912
Brief Title
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
Official Title
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
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.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound, Patient Satisfaction, Patient Preference, Surgical Incision
Keywords
scar, dermatologic surgery, wound healing, wound of skin, skin cancer, surgical incision, patient satisfaction, patient preference, cosmetic outcome, scar appearance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient will have the surgical scar treated with either type of intervention
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydrocolloid dressing arm
Arm Type
Experimental
Arm Description
After informed consent and closing the wound with the sutures, the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days (Experimental)
Arm Title
Petrolatum jelly dressing arm
Arm Type
Active Comparator
Arm Description
and the other group of patients (control), after closing the wound with the sutures, the scar will be covered with petrolatum jelly during this time period, which has to be re-applied daily.
Intervention Type
Device
Intervention Name(s)
Hydrocolloid dressing
Intervention Description
A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
Intervention Type
Other
Intervention Name(s)
Petrolatum jelly dressing
Intervention Description
The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.
Primary Outcome Measure Information:
Title
Cosmetic outcome
Description
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Time Frame
7 days
Title
Cosmetic outcome
Description
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Time Frame
30 days
Title
Cosmetic outcome
Description
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Complication rate
Description
Complication rate including hematoma, seroma, wound infection requiring antibiotics, opening and drainage of wound, dehiscence. Complications will be assessed by physicians other than operating surgeon
Time Frame
7 days, 30 days, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult > 18 years of age
Linear scars
Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention
Exclusion Criteria:
Scar localization on acral or hair bearing sites
Patients unable to converse in English
Patients requiring flap or graft for closure of wound
History of allergy to adhesives
Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
Use of hydrocolloid dressings for post-operative wound care in the past
Facility Information:
Facility Name
IU Health Physicians Dermatology Meridian Crossing
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syril Keena T Que, MD, MPH
Phone
317-944-4000
Email
sque@iuhealth.org
First Name & Middle Initial & Last Name & Degree
Syril Keena T Que, MD, MPH
First Name & Middle Initial & Last Name & Degree
Maria C Bell, MD
First Name & Middle Initial & Last Name & Degree
Claudia Morr
First Name & Middle Initial & Last Name & Degree
Arslan Iqbal, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34993497
Citation
Holmes SP, Rivera S, Hooper PB, Slaven JE, Que SKT. Hydrocolloid dressing versus conventional wound care after dermatologic surgery. JAAD Int. 2021 Dec 21;6:37-42. doi: 10.1016/j.jdin.2021.11.002. eCollection 2022 Mar.
Results Reference
background
Learn more about this trial
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
We'll reach out to this number within 24 hrs