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NCT03561376 · ClinicalTrials.gov registry record · Early Phase 1
Zinc Oxide Versus Petrolatum Following Skin Surgery
A Early Phase 1 study of Surgical Site Infection and Surgical Wound, sponsored by Melissa Pugliano-Mauro.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03561376: Recruiting Early Phase 1 study of Surgical Site Infection and Surgical Wound, sponsored by Melissa Pugliano-Mauro.
NCT03561376 is a Early Phase 1 study of Surgical Site Infection and Surgical Wound that is actively recruiting participants, run by Melissa Pugliano-Mauro. The registered enrollment target is 30 participants, below the 567-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03561376, a Early Phase 1 study of Surgical Site Infection and Surgical Wound, is actively recruiting participants, sponsored by Melissa Pugliano-Mauro.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Topical zinc oxide vs. petrolatum post-surgical scars
Study Locations (1)
Pennsylvania
- UPMC Dermatology St. Margaret - Pittsburgh, PA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2026-10-30 |
| Phase | Early Phase 1 |
What NCT03561376 shows while recruiting
NCT03561376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 567-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (95% lower).
The record links to 6 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 1 intervention - of which Topical zinc oxide vs. petrolatum post-surgical scars is the first listed.
NCT03561376 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03561376 about?
NCT03561376 is a clinical study titled "Zinc Oxide Versus Petrolatum Following Skin Surgery". 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. Patient...
What is the current status of trial NCT03561376?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-09-01. Estimated completion is 2026-10-30.
What conditions does trial NCT03561376 study?
This clinical trial studies the following conditions: Surgical Site Infection, Surgical Wound, Scar, Surgery--Complications, Hypertrophic Scar.
What interventions are being tested in trial NCT03561376?
The interventions under investigation include: Topical zinc oxide vs. petrolatum post-surgical scars (DRUG).
Who is sponsoring clinical trial NCT03561376?
This trial is sponsored by Melissa Pugliano-Mauro, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03561376 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03561376's enrollment target sits among peer trials
30 24th of 25 higher than 2 of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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