Surgical Site InfectionNCT07844681
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
A study testing Cyanoacrylate Skin Adhesive, Fast Gut Running Epidermal Suture Closure and Vicryl Rapide Running Epidermal Suture Closure in people with Surgical Site Infection and Skin Cancer, run by University of Minnesota at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Skin Cancer, Wound Healing
- What is being tested?
- Cyanoacrylate Skin Adhesive, Fast Gut Running Epidermal Suture Closure and Vicryl Rapide Running Epidermal Suture Closure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2026to 30 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ability to provide informed consent
- Ability to read at a 5th grade level or above, needed for survey administration
Who cannot join
- 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
- Prior radiation therapy to the surgical site
- Current use of systemic antibiotics for an unrelated medical condition at the time of surgery
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- Concurrent participation in another interventional research study that could confound wound healing or infection outcomes
- Inability to comply with study procedures or follow-up visits
- Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study outcomes
- Children
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Oxboro Dermatology Clinic
Minneapolis, Minnesota, 55420
Andrew Fay, 612-625-8625, afay@umn.edu
University of Minnesota Dermatologic Surgery Clinic - CSC
Minneapolis, Minnesota, 55455
Andrew Fay, 612-625-8625, afay@umn.edu
Chandler Rundle, MD
University of Minnesota Dermatologic Surgery Clinic - MG
Minneapolis, Minnesota, 55455
Andrew Fay, 612-625-8625, afay@umn.edu
Chandler Rundle, MD
About this study
Official title: A Prospective Randomized Study of Surgical Site Infection After Linear Repair With or Without Cyanoacrylate Skin Adhesive Following Mohs Micrographic Surgery and Wide Local Excision
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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection, Skin Cancer, Wound Healing
- Being tested
- Cyanoacrylate Skin Adhesive, Fast Gut Running Epidermal Suture Closure, Vicryl Rapide Running Epidermal Suture Closure, Prolene Running Epidermal Suture Closure
- Keywords
- Cyanoacrylate skin adhesive, 2-octyl cyanoacrylate, MMS, Mohs micrographic surgery, Surgical site infection, Wound care burden, Antibiotic use
- Medical subject headings
- Surgical Wound Infection, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate Skin AdhesiveDevice
Also called 2-Octyl Cyanoacrylate
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.
Fast Gut Running Epidermal Suture ClosureProcedure or surgery
Standardized 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 ClosureProcedure or surgery
Standardized running epidermal closure will be performed using Vicryl Rapide absorbable suture material after Mohs micrographic surgery or wide local excision.
Prolene Running Epidermal Suture ClosureProcedure or surgery
Standardized running epidermal closure will be performed using Prolene non-absorbable suture material after Mohs micrographic surgery or wide local excision.
| Study group | Role | What they receive |
|---|---|---|
| Fast Gut Sutures With Adhesive | Experimental | Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures followed by cyanoacrylate skin adhesive. Receives: Device: Cyanoacrylate Skin Adhesive; Procedure: Fast Gut Running Epidermal Suture Closure |
| Fast Gut Sutures Without Adhesive | Active comparator | Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures without cyanoacrylate skin adhesive. Receives: Procedure: Fast Gut Running Epidermal Suture Closure |
| Vicryl Rapide Sutures With Adhesive | Experimental | Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures followed by cyanoacrylate skin adhesive. Receives: Device: Cyanoacrylate Skin Adhesive; Procedure: Vicryl Rapide Running Epidermal Suture Closure |
| Vicryl Rapide Sutures Without Adhesive | Active comparator | Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures without cyanoacrylate skin adhesive. Receives: Procedure: Vicryl Rapide Running Epidermal Suture Closure |
| Prolene Sutures With Adhesive | Experimental | Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures followed by cyanoacrylate skin adhesive. Receives: Device: Cyanoacrylate Skin Adhesive; Procedure: Prolene Running Epidermal Suture Closure |
| Prolene Sutures Without Adhesive | Active comparator | Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures without cyanoacrylate skin adhesive. Receives: Procedure: Prolene Running Epidermal Suture Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after Mohs micrographic surgery or wide local excision
Secondary outcomes (8)
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.
Measured: 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.
Measured: 7 to 14 days and 30 days after surgery
Treatment Satisfaction
Treatment satisfaction will be assessed using the Oxford Skin Cancer Treatment Scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Oct 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing Mohs micrographic surgery or wide local excision 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. Within the absorbable suture stratum, participants will be randomized to fast gut or Vicryl Rapide and to adhesive use or no adhesive. Within the non-absorbable suture stratum, participants will receive Prolene and will be randomized to adhesive use or no adhesive.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chandler Rundle, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844681
- Sponsor's protocol ID
- DERM-2026-35119
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes