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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
Sponsor:
Information provided by (Responsible Party):
Lauren Crow, University of Pittsburgh

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.).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Split scar study (petrolatum vs. zinc oxide)
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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%.

  5. 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

  6. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lauren Crow, MD 4126474279 crowld@upmc.edu

Locations
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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         
Sponsors and Collaborators
Lauren Crow
Investigators
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Principal Investigator: Lauren Crow, MD Resident Physician, PGY-3
Publications of Results:
Other Publications:
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Responsible Party: Lauren Crow, Resident Physician, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03561376    
Other Study ID Numbers: STUDY19050135
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lauren Crow, University of Pittsburgh:
Scar
Additional relevant MeSH terms:
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Surgical Wound Infection
Cicatrix, Hypertrophic
Surgical Wound
Cicatrix
Fibrosis
Pathologic Processes
Wounds and Injuries
Wound Infection
Infections
Postoperative Complications
Petrolatum
Zinc Oxide
Emollients
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs