Zinc Oxide Versus Petrolatum Following Skin Surgery

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelissa Pugliano-Mauro

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 volunteers

Qualifiers

≥ 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

Design model

Single group

Treatments tested in this trial

  • Topical zinc oxide vs. petrolatum post-surgical scars

    Drug

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single arm - split scar studyOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
1 week
3

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

Time frame
To be assessed at 8 weeks and six months post-operative follow-up
4

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%.

Time frame
weeks 1 and 4 weeks post-operative

Secondary outcomes

1

Surgical site infection

As above. Any erythema, pus formation, or skin changes necessitating topical or systemic antibiotics.

Time frame
1 week, 4 weeks, 8 weeks, six months post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Melissa Pugliano-Mauro

Lead sponsor

University of Pittsburgh

Sponsor institution