- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07798752
Comparison of Primary Closure Vs Open Wound in Pilonidal Sinus Excision.
Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.
The goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults.
The main question this study aims to answer is:
Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who receive primary closure with patients who receive the open technique after removal of the pilonidal sinus. The study will include 68 men and women between 18 and 75 years of age. Participants will be randomly assigned to one of the two treatment groups.
Participants will:
Undergo surgery using either primary closure or the open technique. Attend follow-up visits after surgery. Have the surgical wound examined 7 days after the procedure. Provide information about their health, medical history, and recovery. The study will record whether participants develop wound infection, including swelling, redness, or pus or clear fluid coming from the wound. The study will be conducted in the General Surgery Department at Medical Institute Haytabad Medical Complex, Peshawar.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Detailed Description
Pilonidal sinus is a chronic condition involving the skin and subcutaneous tissue in the sacrococcygeal or natal cleft region. It commonly presents with one or more midline openings, local pain, redness, swelling, or discharge. Surgical treatment is frequently required for symptomatic disease. However, the most appropriate method of wound management after excision remains uncertain. Primary closure may allow faster wound healing and reduce the period of open wound care, whereas the open technique may reduce tension on the wound but requires healing by secondary intention and regular dressing care.
This randomized controlled trial will compare two surgical approaches for the treatment of pilonidal sinus: primary closure and open healing. The study will be conducted in the General Surgery Department of Hayatabad Medical COmplex, Peshawar, after approval from the relevant institutional ethical review board and the research department of the College of Physicians and Surgeons Pakistan, Karachi.
Eligible participants who provide written informed consent will be assigned to one of two treatment groups using blocked randomization:
Group A: Excision of the pilonidal sinus followed by primary closure. Group B: Excision of the pilonidal sinus followed by open wound management and healing by secondary intention.
Before surgery, the research team will record relevant demographic and clinical information. Participants will undergo a clinical examination and routine preoperative assessment according to institutional practice. The surgical procedures will be performed under appropriate anesthesia by, or under the supervision of, a qualified general surgeon.
For participants in Group A, the sinus and surrounding diseased tissue will be excised down to the level of the sacral fascia. Any secondary tracts identified during surgery will also be removed. After achieving hemostasis, the wound will be closed in layers using polypropylene sutures. The closure will include approximation of the deeper tissues and skin. A suction drain may be placed when clinically indicated. The wound will then be covered with an appropriate sterile dressing.
For participants in Group B, the sinus and surrounding diseased tissue will be excised down to the sacral fascia. After hemostasis, the resulting cavity will be packed with povidone-iodine-soaked gauze. The initial packing will be removed approximately 48 hours after surgery. The wound will then remain open and will be managed with regular dressings until healing is complete. Participants in this group will attend outpatient follow-up visits, generally on a weekly basis or as clinically required.
Participants in both groups will receive postoperative care according to the hospital's standard practice. This may include analgesics, wound-care instructions, advice regarding hygiene, and instructions to return to the hospital if they develop worsening pain, fever, swelling, redness, or discharge. Follow-up assessment will be performed by the research team under the supervision of a consultant surgeon.
Information collected during the study will be recorded on a structured data-collection proforma. Each participant will be assigned a study identification number. Personal information will be kept confidential and will be accessed only by authorized members of the research team. The study findings will be analyzed to compare the postoperative wound outcomes of the two surgical techniques.
The study is intended to provide local clinical evidence regarding the choice between primary closure and open wound management after pilonidal sinus excision. The findings may help surgeons and healthcare professionals make evidence-based decisions about postoperative management and patient counseling.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
KPK
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Peshawar, KPK, Paquistão, 25000
- Hayatabad Medical Complex, Peshawar
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
INCLUSION CRITERIA:
- Male &Female
- Age between (18-75) Years
- Patients with pilonidal sinus as defined in the operational definition.
EXCLUSION CRITERIA:
- Patients with debilitating disease
- Patients with immunocompromised state like malignancy, and tuberculosis.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Primary Closure Technique
Patients undergo excision of the pilonidal sinus and surrounding tissue down to the sacral fascia, followed by closure with polypropylene sutures.
A suction drain (Radivac system) is placed, and vertical mattress sutures are used to approximate skin and subcutaneous tissue.
|
Excision of sinus tract with closure using Prolene sutures and placement of suction drain.
Outros nomes:
|
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Comparador Ativo: Open Technique
Patients undergo excision of the pilonidal sinus with surrounding tissue down to sacral fascia.
The wound is left open and packed with pyodine-soaked gauze.
Patients return for weekly outpatient follow-up until complete healing.
|
Excision of sinus tract with open wound packing and secondary healing.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Wound Infection
Prazo: From surgery to 30 days post-operation
|
Frequency of wound infection within 30 days post-surgery
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From surgery to 30 days post-operation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Wound healing time
Prazo: From date of Surgery until 90 days.
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Healing assessed weekly until closure.
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From date of Surgery until 90 days.
|
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Surgery time
Prazo: During surgical procedure.
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Duration of intervention recorded in minutes.
|
During surgical procedure.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Jabbar MS, Bhutta MM, Puri N. Comparison between primary closure with Limberg Flap versus open procedure in treatment of pilonidal sinus, in terms of frequency of post-operative wound infection. Pak J Med Sci. 2018 Jan-Feb;34(1):49-53. doi: 10.12669/pjms.341.13929.
- Kober MM, Alapati U, Khachemoune A. Treatment options for pilonidal sinus. Cutis. 2018 Oct;102(4):E23-E29.
- Iesalnieks I, Ommer A. The Management of Pilonidal Sinus. Dtsch Arztebl Int. 2019 Jan 7;116(1-2):12-21. doi: 10.3238/arztebl.2019.0012.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RMI_QAD_RCT_PILONOIDAL_sINUS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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