An interventional study of Cyanoacrylate Skin Adhesive and Fast Gut Running Epidermal Suture Closure in Surgical Site Infection, Skin Cancer and Wound Healing, sponsored by University of Minnesota. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
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.
Surgical site infection is an uncommon but clinically important complication after dermatologic surgery. Linear repairs are frequently performed after Mohs micrographic surgery and wide local excision, and closure technique may affect infection risk, wound healing, scar quality, and patient experience.
This is a prospective, randomized, stratified parallel group clinical study evaluating postoperative outcomes after standardized running epidermal suture closure with or without cyanoacrylate skin adhesive. Adult patients undergoing Mohs micrographic surgery or wide local excision for skin cancer will be screened on the day of surgery. Participants will be eligible if the surgical defect is suitable for linear repair using standardized running epidermal sutures.
Participants will be stratified by suture type. In the absorbable suture stratum, participants will be randomized using a 2×2 factorial design to fast gut or Vicryl Rapide suture material and to adhesive use or no adhesive. In the non-absorbable suture stratum, participants will receive Prolene and will be randomized to closure with or without cyanoacrylate skin adhesive.
All participants will undergo Mohs micrographic surgery or wide local excision as part of standard clinical care. Research procedures include randomization of closure approach, standardized wound photography, follow-up assessments at approximately 2 weeks and 3 months, documentation of infection or suspected infection, wound healing assessment, adverse event assessment, and patient-reported outcome measures.
The primary outcome is surgical site infection within 30 days following linear repair. Secondary outcomes include antibiotic use, wound healing metrics, patient-reported treatment satisfaction and wound care burden, scar quality using the Patient and Observer Scar Assessment Scale 3.0 Linear Scar Version, culture results and treatment descriptions when infection is suspected, health care utilization related to wound concerns, and adverse events.
Exclusion Criteria:
Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures followed by cyanoacrylate skin adhesive.
Device: Cyanoacrylate Skin Adhesive · Procedure: Fast Gut Running Epidermal Suture Closure
Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures without cyanoacrylate skin adhesive.
Procedure: Fast Gut Running Epidermal Suture Closure
Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures followed by cyanoacrylate skin adhesive.
Device: Cyanoacrylate Skin Adhesive · Procedure: Vicryl Rapide Running Epidermal Suture Closure
Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures without cyanoacrylate skin adhesive.
Procedure: Vicryl Rapide Running Epidermal Suture Closure
Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures followed by cyanoacrylate skin adhesive.
Device: Cyanoacrylate Skin Adhesive · Procedure: Prolene Running Epidermal Suture Closure
Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures without cyanoacrylate skin adhesive.
Procedure: Prolene Running Epidermal Suture Closure
Cyanoacrylate 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.
Also known as: 2-Octyl Cyanoacrylate
Standardized running epidermal closure will be performed using fast gut absorbable suture material after Mohs micrographic surgery or wide local excision.
Standardized running epidermal closure will be performed using Vicryl Rapide absorbable suture material after Mohs micrographic surgery or wide local excision.
Standardized running epidermal closure will be performed using Prolene non-absorbable suture material after Mohs micrographic surgery or wide local excision.
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 excision
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 surgery
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 surgery
Treatment Satisfaction
Treatment satisfaction will be assessed using the Oxford Skin Cancer Treatment Scale.
Time frame: 2 weeks and 3 months after surgery
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 surgery
Scar Quality
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale 3.0 Linear Scar Version. Participants will complete the patient scale, and a trained blinded assessor will complete the observer scale using standardized 3-month wound photographs.
Time frame: 3 months after surgery
Culture Results and Infection Treatment
For wounds with suspected infection, culture organisms, antibiotic selection, treatment course, and subsequent clinical course will be summarized descriptively.
Time frame: Within 30 days after surgery
Health Care Utilization Related to Wound Concerns
Urgent care visits, emergency department evaluations, specialty consultations, or hospitalizations related to postoperative infection or wound complications will be documented.
Time frame: Baseline through 3 months after surgery
Adverse Events
Adverse events will include hematoma, allergic or irritant contact dermatitis related to suture material or cyanoacrylate adhesive, and other unexpected surgical or wound-related adverse events.
Time frame: Baseline through 3 months after surgery
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University of Minnesota