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Completed

NCT Number: NCT01659983

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

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

Completed

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vachira hospital, Dusit, Bangkok, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients age 18 years or older
  • 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

  • Non-immunocompromised hosts which include
  • AIDS
  • History of end-stage renal disease (ESRD)
  • History of autoimmune disease (SLE)
  • Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
  • Cirrhosis with ascites
  • Morbid obesity (BMI > 40 kg/m2)
  • Non-pregnant women
  • Willing to participate and provide written informed consent

Treatment and study plan

Primary wound closure

Procedure

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Cost of treatment

    Time frame: 1 month after operation

    Both direct and indirect costs of treatment will be recorded

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • Chonburi hospital
  • Lampang Hospital
  • Pathumtani Hospital
  • Surin Hospital
  • Thammasat Hospital
  • Vachira hospital

Registry information

Official study title

Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2012
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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