Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Andrew Fay
- Numer telefonu: 612-625-8625
- E-mail: afay@umn.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Chandler Rundle, MD
- Numer telefonu: 612-625-8625
- E-mail: rundle1@umn.edu
Lokalizacje studiów
-
-
Minnesota
-
Minneapolis, Minnesota, Stany Zjednoczone, 55420
- Oxboro Dermatology Clinic
-
Kontakt:
- Andrew Fay
- Numer telefonu: 612-625-8625
- E-mail: afay@umn.edu
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota Dermatologic Surgery Clinic - CSC
-
Kontakt:
- Andrew Fay
- Numer telefonu: 612-625-8625
- E-mail: afay@umn.edu
-
Główny śledczy:
- Chandler Rundle, MD
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota Dermatologic Surgery Clinic - MG
-
Kontakt:
- Andrew Fay
- Numer telefonu: 612-625-8625
- E-mail: afay@umn.edu
-
Główny śledczy:
- Chandler Rundle, MD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Fast Gut Sutures With Adhesive
Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures followed by cyanoacrylate skin adhesive. |
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.
Inne nazwy:
Standardized running epidermal closure will be performed using fast gut absorbable suture material after Mohs micrographic surgery or wide local excision. |
|
Aktywny komparator: Fast Gut Sutures Without Adhesive
Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures without cyanoacrylate skin adhesive. |
Standardized running epidermal closure will be performed using fast gut absorbable suture material after Mohs micrographic surgery or wide local excision. |
|
Eksperymentalny: Vicryl Rapide Sutures With Adhesive
Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures followed by cyanoacrylate skin adhesive. |
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.
Inne nazwy:
Standardized running epidermal closure will be performed using Vicryl Rapide absorbable suture material after Mohs micrographic surgery or wide local excision. |
|
Aktywny komparator: Vicryl Rapide Sutures Without Adhesive
Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures without cyanoacrylate skin adhesive. |
Standardized running epidermal closure will be performed using Vicryl Rapide absorbable suture material after Mohs micrographic surgery or wide local excision. |
|
Eksperymentalny: Prolene Sutures With Adhesive
Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures followed by cyanoacrylate skin adhesive. |
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.
Inne nazwy:
Standardized running epidermal closure will be performed using Prolene non-absorbable suture material after Mohs micrographic surgery or wide local excision. |
|
Aktywny komparator: Prolene Sutures Without Adhesive
Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures without cyanoacrylate skin adhesive. |
Standardized running epidermal closure will be performed using Prolene non-absorbable suture material after Mohs micrographic surgery or wide local excision. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Surgical Site Infection Within 30 Days After Linear Repair
Ramy czasowe: Within 30 days after Mohs micrographic surgery or wide local excision
|
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. |
Within 30 days after Mohs micrographic surgery or wide local excision
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Systemic Antibiotic Use
Ramy czasowe: Baseline through 30 days after surgery
|
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. |
Baseline through 30 days after surgery
|
|
Wound Healing Complications
Ramy czasowe: 7 to 14 days and 30 days after surgery
|
Wound healing will be assessed by documenting dehiscence, necrosis, delayed epithelialization, and other healing-related complications. |
7 to 14 days and 30 days after surgery
|
|
Treatment Satisfaction
Ramy czasowe: 2 weeks and 3 months after surgery
|
Treatment satisfaction will be assessed using the Oxford Skin Cancer Treatment Scale. |
2 weeks and 3 months after surgery
|
|
Wound Care Burden
Ramy czasowe: 2 weeks after surgery
|
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. |
2 weeks after surgery
|
|
Scar Quality
Ramy czasowe: 3 months after surgery
|
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. |
3 months after surgery
|
|
Culture Results and Infection Treatment
Ramy czasowe: Within 30 days after surgery
|
For wounds with suspected infection, culture organisms, antibiotic selection, treatment course, and subsequent clinical course will be summarized descriptively. |
Within 30 days after surgery
|
|
Health Care Utilization Related to Wound Concerns
Ramy czasowe: Baseline through 3 months after surgery
|
Urgent care visits, emergency department evaluations, specialty consultations, or hospitalizations related to postoperative infection or wound complications will be documented. |
Baseline through 3 months after surgery
|
|
Adverse Events
Ramy czasowe: Baseline through 3 months after surgery
|
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. |
Baseline through 3 months after surgery
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Chandler Rundle, MD, University of Minnesota
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DERM-2026-35119
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .