Zinc Oxide Versus Petrolatum Following Skin Surgery

NCT03561376 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19050135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Hypertrophic Scar

Keywords

Scar

Outcome Measures

Primary Outcomes (6)

• 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.

  8 weeks

• 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.

  1 week

• 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

  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

  Will assess change in % linear epidermal seal between weeks 1 and 4. The score will range from 0-100%.

  weeks 1 and 4 weeks post-operative

• POSAS (patient and observer scar assessment score)

  Range from 6-60. Higher score indicates greater patient satisfaction and better overall cosmesis of scar

  Six months post-operative follow-up

• 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.

  4 weeks

Secondary Outcomes (1)

• Surgical site infection

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

Study Arms (1)

Single arm - split scar study

OTHER

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

Interventions

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.

Single arm - split scar study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)
• Grossly uninfected site

You may not qualify if:

• ≤ 18 years
• Visibly asymmetric linear scar
• Grossly infected surgical site
• History of allergy to topical zinc oxide

Sponsors & Collaborators

• Melissa Pugliano-Mauro: lead

Study Sites (1)

UPMC Dermatology St. Margaret

Pittsburgh, PA, Pennsylvania, 15213, United States

RECRUITING

Related Publications (2)

• Kantor J. The SCAR (Scar Cosmesis Assessment and Rating) scale: development and validation of a new outcome measure for postoperative scar assessment. Br J Dermatol. 2016 Dec;175(6):1394-1396. doi: 10.1111/bjd.14812. Epub 2016 Oct 17. No abstract available.

  PMID: 27292082 BACKGROUND

• Thompson CB, Wiemken TL, Brown TS. Effect of Postoperative Dressing on Excisions Performed on the Leg: A Comparison Between Zinc Oxide Compression Dressings Versus Standard Wound Care. Dermatol Surg. 2017 Nov;43(11):1379-1384. doi: 10.1097/DSS.0000000000001209.

  PMID: 28654576 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection; Cicatrix; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Lauren Crow, MD

  Resident Physician, PGY-3

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Crow, MD

CONTACT

4126474279; crowld@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Director, Mohs Surgery Program, Director Mohs Micrographic Surgery and Dermatologic Oncology Fellowship

Model Details: Split scar study (petrolatum vs. zinc oxide)

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 19, 2018
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)