About this trial
Patients undergoing routine surgery in the Department of Dermatology for any indication on non-scalp skin and closed in linear fashion with scar greater than or equal to 4.5cm in length will be invited to participate in this split scar, head to head study comparing zinc oxide and petrolatum. Patients will apply respective ointments to each half of scar daily for one month and maintain a log of these activities. They will be seen at 1 week, 4 weeks, 8 weeks, and 6 months post-operatively for photographic scar assessment and to complete the patient portion of the Patient and Observer Scar Assessment Scale (POSAS), a quantitative objective assessment of scar appearance. Trained observers (board-certified dermatologists) will score the observer portion of the scale. POSAS outcomes, post-operative infections, linear density of epidermal seal will be assessed at the 1 week, 4 weeks, 8 weeks, and 6 months post-operative periods and compared between the two groups. Participants will have parking validated for all visits and upon completion of all portions of the study will receive a standardized skin care gift bag containing samples for hypoallergenic skin care products (washes, moisturizers, etc.).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥ 18 years of age
Linear closure, non-scalp site
≥ 4.5 cm in length (final incision/closure length)
End to end symmetry (surgical site is not grossly asymmetric from end to end)
Disqualifiers
≤ 18 years
Visibly asymmetric linear scar
Grossly infected surgical site
History of allergy to topical zinc oxide
Trial design
Single group
Treatments tested in this trial
Topical zinc oxide vs. petrolatum post-surgical scars
DrugFollowing 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.
Treatment groups
Trial outcomes
Primary outcomes
POSAS (patient and observer scar assessment score)
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
% 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
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
Will assess change in % linear epidermal seal between weeks 1 and 4. The score will range from 0-100%.
Secondary outcomes
Surgical site infection
As above. Any erythema, pus formation, or skin changes necessitating topical or systemic antibiotics.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Melissa Pugliano-Mauro
Lead sponsor
University of Pittsburgh
Sponsor institution