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

29 augusti 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

76

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Primary Closure
Aktiv komparator: 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.
Andra namn:
  • Surgical excision with open wound management

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Wound Infection
Tidsram: From surgery to 30 days post-operation
Frequency of wound infection within 30 days post-surgery
From surgery to 30 days post-operation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Wound healing time
Tidsram: From date of Surgery until 90 days.
Healing assessed weekly until closure.
From date of Surgery until 90 days.
Surgery time
Tidsram: During surgical procedure.
Duration of intervention recorded in minutes.
During surgical procedure.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2025

Primärt slutförande (Faktisk)

5 augusti 2026

Avslutad studie (Faktisk)

10 augusti 2026

Studieregistreringsdatum

Först inskickad

21 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

29 augusti 2026

Första postat (Faktisk)

1 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

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Nej

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Nej

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