- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07686913
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions (STRIP-CS)
A Randomized Prospective Trial Comparing Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method.
Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions.
Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups.
The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Matthew Perera, DO, MS
- Número de teléfono: 8184800214
- Correo electrónico: matthew.perera@ruhealth.org
Ubicaciones de estudio
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California
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Moreno Valley, California, Estados Unidos, 92555
- Reclutamiento
- Riverside University Health System Medical Center
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Contacto:
- Matthew X Perera, DO, MS
- Número de teléfono: 8184800214
- Correo electrónico: mattpereraruhs@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female patients age 18 years or older
- Pregnant patients undergoing cesarean delivery at Riverside University Health System Medical Center (RUHS)
- Able and willing to provide informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to Steri-Strip™ materials or adhesives
- Inability or unwillingness to provide informed consent
- Anticipated inability to complete the 30-day postpartum follow-up evaluation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Standard Closure + Steri-Strips
Participants undergo standard cesarean skin closure followed by application of Steri-Strip™ skin closure strips according to a standardized study protocol.
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Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.
Standard skin closure performed following cesarean delivery according to institutional practice.
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Comparador activo: Standard Closure Alone
Participants undergo standard cesarean skin closure without application of Steri-Strip™ skin closure strips.
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Standard skin closure performed following cesarean delivery according to institutional practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Cesarean Section Wound Complications
Periodo de tiempo: Within 30 days postpartum
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Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.
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Within 30 days postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of Hospital Stay
Periodo de tiempo: From cesarean delivery until hospital discharge (up to 7 days)
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Duration of hospitalization measured from cesarean delivery until discharge.
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From cesarean delivery until hospital discharge (up to 7 days)
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Readmission Related to Wound Complications
Periodo de tiempo: Within 30 days postpartum
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Hospital readmission attributable to wound infection, seroma, or wound separation/dehiscence following cesarean delivery.
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Within 30 days postpartum
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Cost of Wound Management
Periodo de tiempo: From cesarean delivery through 30 days postpartum
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Comparison of direct healthcare costs associated with wound closure materials and management of postoperative wound complications between study groups.
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From cesarean delivery through 30 days postpartum
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Herman A, Kerre S, Stras A, Desmedt B. Two Additional Cases of Allergic Contact Dermatitis Caused by Wound Closure Tape Steri-Strip3M. Contact Dermatitis. 2025 Jul;93(1):68-70. doi: 10.1111/cod.14788. Epub 2025 Mar 20. No abstract available.
- Hall JD, Schwartz E. Solving "T" Junction Wound Breakdown With a Single Tension-reducing Device. Plast Reconstr Surg Glob Open. 2025 Aug 15;13(8):e6882. doi: 10.1097/GOX.0000000000006882. eCollection 2025 Aug.
- Dominoni M, Torella M, Molitierno R, Fordellone M, Saccone G, Colacurci D, Lagana AS, Pano MR, Gardella B, La Verde M. Single-versus double-layer uterine closure at the time of cesarean delivery and risk of uterine scar niche: a systematic review and meta-analysis of randomized trials. Arch Gynecol Obstet. 2025 Oct;312(4):1095-1106. doi: 10.1007/s00404-025-08151-y. Epub 2025 Aug 20.
- Zempsky WT, Parrotti D, Grem C, Nichols J. Randomized controlled comparison of cosmetic outcomes of simple facial lacerations closed with Steri Strip Skin Closures or Dermabond tissue adhesive. Pediatr Emerg Care. 2004 Aug;20(8):519-24. doi: 10.1097/01.pec.0000136068.45198.ae.
- Sah N, Punga R, Kumar A, Shivhare P, Singh AK, Sah S, Shekhar A. The surgical outcome of sutureless skin closures using Octyl-2-cyanoacrylate (Dermabond) versus Steri-Strip. Natl J Maxillofac Surg. 2024 May-Aug;15(2):307-312. doi: 10.4103/njms.njms_102_22. Epub 2024 Jul 24.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2357408
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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