Zinc Oxide Versus Petrolatum Following Skin Surgery
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|ClinicalTrials.gov Identifier: NCT03561376|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : April 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Surgical Incision Surgery--Complications Surgical Wound Surgical Site Infection Scar Hypertrophic Scar||Drug: Topical zinc oxide vs. petrolatum post-surgical scars||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Split scar study (petrolatum vs. zinc oxide)|
|Masking:||None (Open Label)|
|Official Title:||Zinc Oxide Versus Petrolatum Following Skin Surgery: A Head-to-head, Prospective, Split-scar Study|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Single arm - split scar study
Surgical closures, at least 4.5cm in length, will be split and zinc oxide ointment applied to half and petrolatum ointment to the other half
Drug: Topical zinc oxide vs. petrolatum post-surgical scars
Following linear closure on non-scalp skin with scar length > 4.5 cm, incision site will be "split" and petrolatum applied to one half and zinc oxide ointment to the other half daily for one month following surgery.
- POSAS (patient and observer scar assessment score) [ Time Frame: 8 weeks ]Patient and observer scar assessment score. Range from 6-60. Higher score indicates greater patient satisfaction and better overall cosmesis of scar. Please note there is an observer and patient POSAS score. Both range from 6-60. The observer scale grades the apparent vascularity, pigmentation, thickness, relief, pliability, and surface area of the scar. The patient scale evaluate the patient's perception of pain, itching, color, stiffness, thickness, irregularity associated with the scar. Each item is graded from 1-10 for a combined minimum to maximum of 6-60.
- Percentage of epidermal linear seal [ Time Frame: 1 week ]% of linear scar that has fully sealed across surgical defect based on visual inspection. 0-100%. Higher percentage reflects greater proportion of visually sealed epidermis upon surgical closure.
- POSAS (patient and observer scar assessment score) change between 8 weeks and six months [ Time Frame: To be assessed at 8 weeks and six months post-operative follow-up ]Will assess for change in POSAS between weeks 8 and six months follow-up. The score will range from 0-54
- Change in % epidermal linear seal between weeks 1 and 4 post-operative [ Time Frame: weeks 1 and 4 weeks post-operative ]Will assess change in % linear epidermal seal between weeks 1 and 4. The score will range from 0-100%.
- POSAS (patient and observer scar assessment score) [ Time Frame: Six months post-operative follow-up ]Range from 6-60. Higher score indicates greater patient satisfaction and better overall cosmesis of scar
- Percentage of epidermal linear seal [ Time Frame: 4 weeks ]% of linear scar that has fully sealed across surgical defect based on visual inspection. 0-100%. Higher percentage reflects greater proportion of visually sealed epidermis upon surgical closure.
- Surgical site infection [ Time Frame: 1 week, 4 weeks, 8 weeks, six months post-operatively ]As above. Any erythema, pus formation, or skin changes necessitating topical or systemic antibiotics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561376
|Contact: Lauren Crow, MDemail@example.com|
|United States, Pennsylvania|
|UPMC Dermatology St. Margaret||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Lina Husienzad, MD|
|Principal Investigator: Lauren Crow, MD|
|Sub-Investigator: Melissa Pugliano-Mauro, MD|
|Principal Investigator:||Lauren Crow, MD||Resident Physician, PGY-3|