Abdominal Midline Wound Closure: Small Tissue Bites Versus Large Tissue Bites
The goal of this clinical trial is to learn whether a small stitch technique works better than a large bite technique for closing midline abdominal surgery wounds in adults having midline laparotomy surgery.
The main questions it aims to answer are:
Does the small stitch technique lower the risk of surgical site infection? Does the small stitch technique lower the risk of wound dehiscence (reopening of the wound)? Researchers will compare the small stitch technique with the large bite technique to see if the small stitch technique leads to fewer wound complications after surgery.
Participants will:
Have their abdominal wound closed using either the small stitch or large bite technique during surgery Attend follow-up visits at 2 weeks and 1 month after surgery Be checked for wound complications, including infection and wound reopening In the small stitch technique, stitches are placed 5 millimeters from the wound edge and 5 millimeters apart. In the large bite technique, stitches are placed 10 millimeters apart.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This clinical trial is designed to evaluate two different methods of closing abdominal wounds after midline laparotomy surgery in adults. A midline laparotomy is a common surgical procedure in which an incision is made along the middle of the abdomen to allow surgeons access to internal organs. Proper closure of this incision is important because complications such as infection or reopening of the wound can lead to pain, delayed recovery, longer hospital stays, and additional treatment.
The study focuses on comparing a "small stitch" technique with the more traditional "large bite" technique used to close the abdominal wall at the end of surgery. Researchers want to determine whether the small stitch method can improve healing and reduce complications after surgery.
In the small stitch technique, sutures are placed approximately 5 millimeters from the edge of the wound and spaced 5 millimeters apart. This approach is designed to distribute tension more evenly across the wound and may help preserve blood supply to the tissues, potentially improving healing. In the large bite technique, stitches are placed farther from the wound edge and farther apart, which is the conventional method commonly used in many surgical settings.
The main goals of the study are to determine:
Whether the small stitch technique reduces the risk of surgical site infections Whether the small stitch technique lowers the chance of wound dehiscence, a serious complication in which the surgical wound partially or completely reopens after surgery Adults undergoing midline laparotomy surgery may be eligible to participate. During the procedure, participants will have their abdominal incision closed using either the small stitch or the large bite technique. The method used will be assigned according to the study protocol so that researchers can fairly compare outcomes between the two groups.
After surgery, participants will continue with routine postoperative care and attend follow-up visits approximately 2 weeks and 1 month after their operation. At these visits, the surgical wound will be examined for signs of infection, delayed healing, wound reopening, pain, or other complications. Researchers will collect and compare the results from both groups to determine which closure method provides better outcomes.
The information gained from this study may help surgeons identify the safest and most effective way to close abdominal incisions, potentially improving recovery and reducing postoperative complications for future patients undergoing abdominal surgery.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Karachi, Pakistán, 75510
- Indus Hospital and Health Network
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
. Age 18-80 years, either sex
- Midline laparotomy (elective or emergency)
- ASA class I-IV
Exclusion Criteria:
- Previous incisional hernia or midline incision
- Contaminated surgery
- ASA V-VI
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Small Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the small stitch technique following midline laparotomy surgery.
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In this technique, sutures are placed approximately 5 millimeters apart using a continuous suturing method.
Otros nombres:
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Comparador activo: Large Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the large stitch technique following midline laparotomy surgery
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In this technique, sutures are placed approximately 10 millimeters apart using a continuous suturing method.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sheath Dehiscence
Periodo de tiempo: 30 days
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Abdominal fascial (sheath) dehiscence, defined as partial or complete separation of the abdominal fascial closure with or without evisceration, assessed by clinical examination of the surgical wound by the treating surgical team.
The outcome will be reported as the number of participants who develop fascial dehiscence during the follow-up period.
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30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skin dehiscence
Periodo de tiempo: 30 days
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Postoperative skin wound dehiscence, defined as partial or complete separation of the skin edges of the surgical incision, assessed by standardized clinical wound examination performed during postoperative follow-up.
The outcome will be reported as the number of participants who develop skin wound dehiscence.
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30 days
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Southampton wound grading
Periodo de tiempo: 30 days
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normal healing, erythema, discharge, purulence
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30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Nazia Lodhi, MBBS, FCPS, Indus Hospital and Health Network
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
Otros números de identificación del estudio
- IHHN_IRB_2024_03_014
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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