Zinc Oxide Versus Petrolatum Following Skin Surgery

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    30
  • sponsor
    Lauren Crow
Updated on 30 April 2022
zinc
scar
skin care
topical zinc oxide
skin surgery
gift
dermatologic surgery
Accepts healthy volunteers

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.).

Description

Patients who have undergone dermatologic excision for any indication with or without Mohs micrographic surgical technique and surgically closed in linear fashion with scar length of greater than or equal to 4.5cm on any site but the scalp will be approached for enrollment in the study. Any closure in which one half of the linear scar appears grossly unequal to or worse than the other (due to any number of causes, such as suture technique, etc.) will be excluded from the study. Any patient whose surgical procedure was deemed as having high risk of post-surgical infection would also be excluded from the study as well as those with known history of topical zinc allergy. Consent will be obtained with one of the trained co-investigators. Included in this consent will be consent to collection of basic patient medical data pertinent to wound healing/scar formation will be obtained, such as history of keloids, smoking, history of diabetes mellitus, history of cancer and/or on chemotherapy, history of transplant, and immunosuppressive status, etc. for the purposes of this research. Risk to patients using zinc oxide ointment has been deemed by the FDA as minimal. Of note, zinc oxide ointment currently is the gold standard treatment for erosive diaper dermatitis on newborns and infants. It is generally deemed safe clinically and its application to other clinical settings outside of diaper rash has not been explored.

Upon providing consent for the study, the patient's surgical closure will be demarcated with sterile inked pen and "V" will be drawn on one end and "Z" on the other. The control, standard of care petrolatum (i.e. Vaseline) will be applied to the side indicated by "V" and the experimental treatment zinc oxide will be applied to the "Z" side. As a general rule, if oriented longitudinally, "Z" will mark distal, "V" will mark proximal. If oriented horizontally (left to right), "V" will mark the left side, "Z" the right. The ointments and standard pressure dressing will be administered in clinic upon closure and consent/enrollment. Patients will be sent home with package containing standard wound dressing materials as well as both zinc oxide and petrolatum.

Patients will be sent home with instructions and wound care materials to perform the following: (1) Keep post surgical pressure dressing in place for 48 hours (2) Gentle soap and water cleansing after 48 hours once daily (3) With daily dressing changes self apply zinc oxide ointment to side indicated by "Z" and petrolatum (vaseline) to side indicated by "V" (3b) Patient will be encouraged to re-mark site Z and V to serve as reminder to enhance compliance (4) Patient will sign off on daily log twice: once upon application of zinc oxide to Z side and upon application of petrolatum to V side. (5) Patient will perform daily dressing changes as above for one month. The application of daily ointment with or without dressing is also routine standard of care at the present time. Draft of patient instructions has been included with this submission.

Patients will be seen at the routine standard of care visit 7 days post-op for suture removal. At this point in time, accompanying dressing will be taken down, cleansed with sterile saline, and patient wounds will be photographed under standardized conditions, with avoidance of any clue as to which ointment was applied to which side. In addition, patients will perform the patient portion of the POSAS (Patient and Observer Scar Assessment Scale v2.0, a validated measure of scar cosmesis, with 6 to 60 scale, with low numbers represent that scar appears most similar to normal skin, whereas 60 indicates that the scar is visually furthest from normal skin, i.e. worst possible scar). Patients will also follow-up at 4 weeks, 8 weeks, and 6 months post-operatively for scar assessment. Patient parking will be validated. For patients requesting optimal close clinical follow-up for post-surgical scars, this appointment schedule represents the highest standard of care. At these visits, photographs will be obtained, and patients will again be asked to complete the patient portion of the POSAS scale. Upon completion of the six month follow-up visit for this pilot study, patients will be given a basic skin care product sample gift bag, containing a standardized collection of samples of hypoallergenic washes and moisturizers. Of note, if a patient is unable to return for the final six month follow-up visit, patients will be allowed to submit electronic photographs (non-standardized, self taken) with clear instructions to send via secure message via MyUPMC, a secure interface allowing for communication between patient's and doctors within the UPMC (University of Pittsburgh Medical Center) network. This option is to be reserved as a last resort. Patients will not receive the gift bag if unable to return for this final study visit. Please note that patient obtained and entered photographs are routinely used clinically for remote assessment of skin disorders for routine clinical follow-up.

Board-certified dermatologists at the end of the study will evaluate the photographs obtained at a later point in the study. Through photographic and/or edited technique if necessary, they will be blinded to which side received zinc oxide and which side received petrolatum. Indeed, the POSAS has been validated with photographic use. In addition, an estimation of the linear proportion of epidermal seal will be evaluated visually based on clinical exam and/or photographs. Specifically, the length of the wound will be measured at this visit and distance of scar containing non grossly apposed skin edges will be measured. The sum of length of non-sealed areas within the V side and within the Z side will be calculated. In addition, clinical evidence of surgical site infection, wound disruption, and/or any other post-surgical complications will be documented.

Upon completion of study visits, POSAS score, epidermal seal, and other clinical data will be statistically analyzed. Compliance rates will be calculated. Primary outcome of POSAS vs. % epidermal seal will be utilized. A total of 30 participants has been established as a goal for this pilot study with guidance from the Clinical and Translational Science Institute at the University of Pittsburgh Medical Center.

The standardized post surgical scar assessment tool (SCAR, Scar Cosmesis Assessment and Rating) will be utilized to objectively record scar outcomes. In addition, photographs of the surgical sites will be taken at each visit. In exchange for their participation, all patient wound care materials will be provided by the clinic.

These research procedures will take place in the surgical suites of the UPMC Falk Dermatology Office Building and the UPMC St. Margaret's Dermatology Office Building. These activities are to take place during the 2018-19 academic year.

Clinical staff at both sites will be involved in the conduct of the study. Patients referred/scheduled to see faculty dermatologic surgeon Dr. Melissa Pugliano-Mauro will be the population pool.

Details
Condition Surgical Incision, Surgery--Complications, Surgical Wound, Surgical Site Infection, Scar, Hypertrophic Scar
Treatment Topical zinc oxide vs. petrolatum post-surgical scars
Clinical Study IdentifierNCT03561376
SponsorLauren Crow
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 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

Exclusion Criteria

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note