The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Procellera is single layer, broad-spectrum antimicrobial wound dressing. Embedded in the dressing are microcell batteries made of elemental silver and zinc applied in a dot-matrix pattern. The bioelectric dressing will be applied to surgical site wound with a hydrogel.
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
University of Miami
Miami, Florida, United States
Healing Rate
The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day.
Time frame: Up to 8 weeks
Average Time to Complete Healing
The average time, measured in the number of days, to complete healing as assessed by treating physician will be reported
Time frame: Up to 8 weeks
Number of Subjects With Complete Healing
The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.
Time frame: Up to 8 weeks
Number of Subjects With Nodule and/or Tunnel Recurrence
The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.
Time frame: Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)
The average pain will be measured using the VAS with scores ranging from 0-100 with the higher score indicating more severe pain. Mean change in score will be compared from baseline to last visit.
Time frame: Up to 8 weeks
Number of Subjects With Tenderness at Surgical Sites
The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.
Time frame: Up to 8 weeks
Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale
The Modified Vancouver Scar Scale (MVSS) is a validated clinical tool used to assess scar quality. It includes four subscales: Vascularity (0-3), Pigmentation (0-2), Pliability (0-5), Height/Thickness (0-3). Each subscale is scored independently, and the scores are summed to produce a total score ranging from 0 to 13. Higher scores indicate worse scar quality (greater abnormality). Lower scores indicate better scar quality (closer to normal skin).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 8 weeks
Amount of Exudate at Surgical Site
The amount of exudate at surgical site will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). Mean change in score will be compared from baseline to last visit.
Time frame: Up to 8 weeks
Shoulder Range of Motion
Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported.
Time frame: Up to 8 weeks
Number of Dressings Used Through to Healing Day
The number of dressings used through to healing day will be reported. Mean change in number of dressings will be compared from baseline to last visit.
Time frame: Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)
The average pain will be measured using the VAS with scores ranging from 0-100 with the higher score indicating more severe pain. Mean score on day 2 will be reported.
Time frame: Day 2 (24 hours post procedure)
Days of Work Lost
Number of reported days of work lost due to the procedure will be reported
Time frame: Up to 8 weeks
Change in Quality of Life as Measured by the DLQI
Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life. Mean change in score will be compared from baseline to last visit.
Time frame: Baseline, Up to 8 weeks
Tissue Analysis of Microbiome
As measured by quantitative 16s recombinant DNA (rDNA) Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples. Mean change in bacterial load from baseline and final visit will be compared and reported in log Colony Forming Unit (CFU)/gram.
Time frame: Up to 8 weeks