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Comparison of Primary Closure Vs Open Wound in Pilonidal Sinus Excision.

29 août 2026 mis à jour par: Yousaf Jan, Hayatabad Medical Complex

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

76

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Hayatabad Medical Complex, Peshawar

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autres noms:
  • Primary Closure
Comparateur actif: 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.
Autres noms:
  • Surgical excision with open wound management

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Wound Infection
Délai: From surgery to 30 days post-operation
Frequency of wound infection within 30 days post-surgery
From surgery to 30 days post-operation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Wound healing time
Délai: From date of Surgery until 90 days.
Healing assessed weekly until closure.
From date of Surgery until 90 days.
Surgery time
Délai: During surgical procedure.
Duration of intervention recorded in minutes.
During surgical procedure.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2025

Achèvement primaire (Réel)

5 août 2026

Achèvement de l'étude (Réel)

10 août 2026

Dates d'inscription aux études

Première soumission

21 août 2026

Première soumission répondant aux critères de contrôle qualité

29 août 2026

Première publication (Réel)

1 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • RMI_QAD_RCT_PILONOIDAL_sINUS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified participant data (demographics, wound infection outcomes, healing times) will be shared upon reasonable request to the principal investigator after study completion. Access will be granted to qualified researchers for academic purposes only.

Délai de partage IPD

IPD and supporting information will be available beginning 6 months after publication of primary results and remain accessible for 5 years.

Critères d'accès au partage IPD

Qualified researchers with a methodologically sound proposal may request access. Requests will be reviewed by the principal investigator. Data will be shared through secure institutional data repositories upon approval.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .