Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis

Overview

Research hypothesis: Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure. Study design: This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis. Setting: Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital Participants: Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis. Outcome: Superficial surgical site infection Period of study: August 2012 – August 2014

Full Title of Study: “Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

Interventions

  • Procedure: Primary wound closure
    • A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.

Arms, Groups and Cohorts

  • Experimental: Primary wound closure
    • A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
  • Active Comparator: Delayed primary wound closure
    • A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation

Clinical Trial Outcome Measures

Primary Measures

  • Superficial surgical site infection (SSI)
    • Time Frame: within 1 month after operation
    • Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows: Infection within 30 days and Involves only skin and subcutaneous tissue of the incision and One of the following: Purulent drainage, organism isolated from culture of fluid or tissue one of the following signs or symptoms: pain or tenderness; localized, swelling, redness, or heat And the superficial incision is deliberately opened by surgeon

Secondary Measures

  • postoperative pain
    • Time Frame: within 3 days after operation
    • • Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
  • Quality of life
    • Time Frame: 1 month after operation
    • Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
  • Cost of treatment
    • Time Frame: 1 month after operation
    • Both direct and indirect costs of treatment will be recorded

Participating in This Clinical Trial

Inclusion criteria 1. Adult patients age 18 years or older 2. Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus 3. Non-immunocompromised hosts which include 1. AIDS 2. History of end-stage renal disease (ESRD) 3. History of autoimmune disease (SLE) 4. Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil) 5. Cirrhosis with ascites 6. Morbid obesity (BMI > 40 kg/m2) 4. Non-pregnant women 5. Willing to participate and provide written informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ramathibodi Hospital
  • Collaborator
    • Thammasat Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Boonying Siribumrungwong, Section for Clinical Epidemiology and Biostatistics – Ramathibodi Hospital
  • Overall Official(s)
    • Boonying Siribumrungwong, MD, Principal Investigator, Ramathibodi Hospital
    • Ammarin Thakkinstian, PhD, Study Chair, Ramathibodi Hospital
    • Patarawan Woratanarat, Study Chair, Ramathibodi Hospital
    • Borwornsom Leerapan, Study Chair, Ramathibodi Hospital
    • Jittunut Hawanon, Study Chair, Thammasat Hospital

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