Comparison of Cosmetic Outcome and Patient Satisfaction Between Staples and Suture Technique for Wound Closure Following Upper Limb Surgeries
A Comparative Study of Wound Outcome and Patient Satisfaction Between Incisions Closed With Staples and Sutures Following Elective Upper Limb Orthopedic Surgeries
Surgical wound closure is an essential component of postoperative care that influences wound healing, infection rates, cosmetic appearance, and patient satisfaction. Sutures are conventionally used for skin closure following orthopedic procedures; however, surgical staples have gained popularity because of their rapid application, secure fixation, and potentially superior cosmetic outcomes. Despite their widespread use, there remains limited evidence comparing cosmetic outcomes and patient satisfaction between staple and suture techniques in upper limb surgeries in the local setting.
This study aims to compare the cosmetic outcome and patient satisfaction between staples and sutures for wound closure following upper limb surgeries at Dhulikhel Hospital. Secondary objectives include comparing wound infection rates and duration of hospital stay between the two techniques.
A prospective comparative study is conducted among adult patients undergoing upper limb surgeries. Patients fulfilling the inclusion and exclusion criteria are recruited consecutively during the study period. Following completion of surgery, wound closure is performed either with interrupted sutures or surgical staples according to the operative plan. Wounds are to be evaluated on postoperative day 2, day 7, and day 14, with further follow-up at 30 days and 6 weeks.
Cosmetic outcome and patient satisfaction are assessed using a 5-point Visual Analogue Scale (VAS). Pain assessment, wound complications including infection, and duration of hospital stay are also documented and compared between the two groups. The findings of this study can help identify the optimal skin closure method for upper limb surgeries and contribute to improved postoperative outcomes and patient satisfaction.
HYPOTHESES OF THE STUDY Null hypothesis (Ho): there is no difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries.
Alternative hypothesis (H1): there is difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries
Hence, Ho : (Cosmetic and Patient satisfaction score) in Suture group = Cosmetic and Patient satisfaction score) in Staples group H1 : (Cosmetic and Patient satisfaction score) in Suture group ≠ (Cosmetic and Patient satisfaction score) in Staples group
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Bagmati
-
Dhulikhel, Bagmati, Nepal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patient (> 18 years and above)
- Any wound more than two centimeters in length
- All closed fracture of upper limb requiring open reduction and internal fixations
- All implant removal and benign tumor excision of upper limb
Exclusion Criteria:
- Open upper limb fracture
- Known metal allergy(nickel, titanium)
- Active infection
- Malignant tumor excision
- Tendon repair
- Closed Reduction Percutaneous Pinning
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Skin Closure with Suture Group
|
Following completion of the upper limb surgical procedure, skin closure is performed using interrupted non-absorbable skin sutures under aseptic precautions.
Skin closure is mattress as it allows for inversion or eversion of the repaired tissue, greater repair strength, and provides a greater area of soft tissue apposition to bone.
|
|
Experimental: Skin Closure with Staple Group
|
Following completion of the upper limb surgical procedure, skin closure is performed using sterile surgical skin staples under aseptic precautions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cosmetic Outcome Assessed by 5-Point Visual Analogue Scale (VAS)
Periodo de tiempo: 1 year
|
Cosmetic outcome following wound closure with staples or sutures will be assessed at 30 days and 6 weeks using a 5-point Visual Analogue Scale (VAS).
The scale ranges from 1 to 5, where 1 indicates excellent cosmetic appearance and 5 indicates very poor cosmetic appearance.
Lower scores indicate better cosmetic outcome.
|
1 year
|
|
Patient Satisfaction Assessed by 5-Point Satisfaction Scale
Periodo de tiempo: 1 year
|
Patient satisfaction regarding wound closure will be assessed at 30 days and 6 weeks using a 5-point satisfaction scale.
The scale ranges from 1 to 5, where 1 indicates extremely satisfied and 5 indicates extremely dissatisfied.
Lower scores indicate greater patient satisfaction.
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain Assessed by 5-Point Pain Scale
Periodo de tiempo: 1 year
|
Postoperative pain at the wound site will be assessed during follow-up visits using a 5-point pain scale ranging from 1 to 5, where 1 indicates no pain and 5 indicates very severe pain.
Lower scores indicate less postoperative pain.
|
1 year
|
|
Surgical Site Infection
Periodo de tiempo: 1 year
|
Surgical site infection will be assessed clinically during postoperative follow-up visits on day 2, day 7, day 14, and day 30.
Infection will be reported as presence or absence of clinical signs including redness, swelling, discharge, or wound tenderness.
|
1 year
|
|
Length of Hospital Stay
Periodo de tiempo: 1 year
|
Length of hospital stay will be measured in days from the date of surgery until discharge from hospital.
Shorter hospital stay indicates improved postoperative recovery.
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Rodeheaver GT, Beltran KA, Green CW, Faulkner BC, Stiles BM, Stanimir GW, Traeland H, Fried GM, Brown HC, Edlich RF. Biomechanical and clinical performance of a new synthetic monofilament absorbable suture. J Long Term Eff Med Implants. 1996;6(3-4):181-98.
- Edlich RF, Panek PH, Rodeheaver GT, Turnbull VG, Kurtz LD, Edgerton MT. Physical and chemical configuration of sutures in the development of surgical infection. Ann Surg. 1973 Jun;177(6):679-88. doi: 10.1097/00000658-197306000-00006. No abstract available.
- Orlinsky M, Goldberg RM, Chan L, Puertos A, Slajer HL. Cost analysis of stapling versus suturing for skin closure. Am J Emerg Med. 1995 Jan;13(1):77-81. doi: 10.1016/0735-6757(95)90248-1.
- Meiring L, Cilliers K, Barry R, Nel CJ. A comparison of a disposable skin stapler and nylon sutures for wound closure. S Afr Med J. 1982 Sep 4;62(11):371-2.
- Chaudhary, P., Shrestha, B. P., Khanal, G. K., Rijal, R., & Maharjan, R. (2017). Randomized controlled trial comparing outcome of use of staples and nylon sutures for closure in elective orthopedic surgery. Health Renaissance, 13(3), 137-143. https://doi.org/10.3126/hren.v13i3.17937
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Dolor
- Manifestaciones neurológicas
- Heridas y Lesiones
- Complicaciones Postoperatorias
- Procesos Patológicos
- Infecciones
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Herida quirúrgica
- Dolor Postoperatorio
- Infección en la herida
- Dehiscencia de herida quirúrgica
- Equipo quirúrgico
- Equipos y suministros
- Dispositivos de fijación quirúrgica
- Suturas
Otros números de identificación del estudio
- 30/23
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .