Surgical Site Infection Clinical Trial
Official title:
Zinc Oxide Versus Petrolatum Following Skin Surgery: A Head-to-head, Prospective, Split-scar Study
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.).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Dermatology St. Margaret | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lauren Crow |
United States,
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 availabl — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Surgical site infection | As above. Any erythema, pus formation, or skin changes necessitating topical or systemic antibiotics. | 1 week, 4 weeks, 8 weeks, six months post-operatively |
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