Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
This study will compare surgical site infection after linear repair with or without cyanoacrylate skin adhesive following Mohs micrographic surgery or wide local excision.
Adult participants undergoing Mohs micrographic surgery or wide local excision for skin cancer with a surgical defect suitable for linear repair will be stratified by suture type and randomized to standardized running epidermal suture closure with or without cyanoacrylate skin adhesive.
The primary outcome is surgical site infection within 30 days after surgery. Secondary outcomes include scar quality, treatment satisfaction, wound care burden, wound healing characteristics, antibiotic use, culture results, health care utilization related to wound concerns, and adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Undergoing Mohs micrographic surgery or wide local excision for skin cancer
Surgical defect suitable for linear repair
Surgical defect suitable for linear repair using standardized running epidermal sutures
Disqualifiers
Requirement for flap, graft, geometric repair, or healing by second intention
Active infection or severe contamination at the surgical site prior to closure
Known allergy or hypersensitivity to cyanoacrylate adhesive, fast gut, Vicryl Rapide, or Prolene
Recurrent tumor at the surgical site
Trial design
Design model
Parallel
Treatments tested in this trial
Cyanoacrylate Skin Adhesive
DeviceCyanoacrylate skin adhesive will be applied in a thin, continuous layer along the repaired wound after hemostasis and epidermal closure are complete. The adhesive is an FDA-approved topical wound closure product used within its labeled indication.
Fast Gut Running Epidermal Suture Closure
Procedure/SurgeryStandardized running epidermal closure will be performed using fast gut absorbable suture material after Mohs micrographic surgery or wide local excision.
Vicryl Rapide Running Epidermal Suture Closure
Procedure/SurgeryStandardized running epidermal closure will be performed using Vicryl Rapide absorbable suture material after Mohs micrographic surgery or wide local excision.
Prolene Running Epidermal Suture Closure
Procedure/SurgeryStandardized running epidermal closure will be performed using Prolene non-absorbable suture material after Mohs micrographic surgery or wide local excision.
Treatment groups
300 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Fast Gut Sutures With AdhesiveExperimental treatment 2 interventions
Group B: Fast Gut Sutures Without AdhesiveActive comparator 1 intervention
Group C: Vicryl Rapide Sutures With AdhesiveExperimental treatment 2 interventions
Group D: Vicryl Rapide Sutures Without AdhesiveActive comparator 1 intervention
Group E: Prolene Sutures With AdhesiveExperimental treatment 2 interventions
Group F: Prolene Sutures Without AdhesiveActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Site Infection Within 30 Days After Linear Repair
Surgical site infection will be assessed within 30 days following linear repair after Mohs micrographic surgery or wide local excision. Surgical site infection is defined as culture-confirmed infection or strong clinical suspicion of infection when a culture cannot be obtained, including purulent discharge, erythema with edema or warmth, drainage consistent with infection, or cellulitis requiring antibiotic therapy.
Time frame
Within 30 days after Mohs micrographic surgery or wide local excisionSecondary outcomes
1
Systemic Antibiotic Use
Prophylactic and postoperative systemic antibiotic use will be documented, including indication, timing, and duration. This includes antibiotics prescribed for suspected infection at follow-up or interval visits.
Time frame
Baseline through 30 days after surgery2
Wound Healing Complications
Wound healing will be assessed by documenting dehiscence, necrosis, delayed epithelialization, and other healing-related complications.
Time frame
7 to 14 days and 30 days after surgery3
Treatment Satisfaction
Treatment satisfaction will be assessed using the Oxford Skin Cancer Treatment Scale.
Time frame
2 weeks and 3 months after surgery4
Wound Care Burden
Wound care burden will be assessed using a brief custom wound-care questionnaire evaluating time spent on wound care, satisfaction with the wound-care regimen, and wound-care preference.
Time frame
2 weeks after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: