Recruiting
Early Phase 1

Zinc Oxide vs. Petrolatum

Sponsor:

Melissa Pugliano-Mauro

Code:

NCT03561376

Conditions

Surgical Incision

Surgery--Complications

Surgical Wound

Surgical Site Infection

Scar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Topical zinc oxide vs. petrolatum post-surgical scars

Study Details

Brief summary:

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.).

Conditions

Surgical Incision

Surgery--Complications

Surgical Wound

Surgical Site Infection

Scar

Study ID

NCT03561376

Start date

Sep 1, 2021

Status verified date

Aug, 2026

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. ≥ 18 years of age
2. Linear closure, non-scalp site
3. ≥ 4.5 cm in length (final incision/closure length)
4. End to end symmetry (surgical site is not grossly asymmetric from end to end)
5. Grossly uninfected site

Exclusion Criteria:

1. ≤ 18 years
2. Visibly asymmetric linear scar
3. Grossly infected surgical site
4. History of allergy to topical zinc oxide

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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

Interventions

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.

Primary outcome measure

  • POSAS (patient and observer scar assessment score) [ Time Frame: 8 weeks ]
  • Percentage of epidermal linear seal [ Time Frame: 1 week ]
  • 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 ]
  • Change in % epidermal linear seal between weeks 1 and 4 post-operative [ Time Frame: weeks 1 and 4 weeks post-operative ]
  • POSAS (patient and observer scar assessment score) [ Time Frame: Six months post-operative follow-up ]
  • Percentage of epidermal linear seal [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Caroline Kettering, MD

4126474200ketteringce@upmc.edu

Locations

UPMC Dermatology St. Margaret

Recruiting

Pittsburgh, PA, Pennsylvania, United States, 15213

Contacts

Caroline Kettering, MD

ketteringce@upmc.edu

Principal Investigator:

Lauren Crow, MD

More Information

Sponsor

Melissa Pugliano-Mauro

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Scar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Melissa Pugliano-Mauro on 2026-09-02.