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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659983
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : April 6, 2016
Sponsor:
Collaborators:
Thammasat Hospital
Chonburi Hospital
Vachira hospital
Pathumtani Hospital
Lampang Hospital
Surin Hospital
Information provided by (Responsible Party):
Boonying Siribumrungwong, Ramathibodi Hospital

Tracking Information
First Submitted Date  ICMJE June 25, 2012
First Posted Date  ICMJE August 8, 2012
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Official Title  ICMJE Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Primary wound closure
  • 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
    Intervention: Procedure: Primary wound closure
Publications * Noorit P, Siribumrungwong B, Thakkinstian A. Clinical prediction score for superficial surgical site infection after appendectomy in adults with complicated appendicitis. World J Emerg Surg. 2018 Jun 18;13:23. doi: 10.1186/s13017-018-0186-1. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2012)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659983
Other Study ID Numbers  ICMJE ID 04-55-18 ว
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boonying Siribumrungwong, Ramathibodi Hospital
Study Sponsor  ICMJE Ramathibodi Hospital
Collaborators  ICMJE
  • Thammasat Hospital
  • Chonburi Hospital
  • Vachira hospital
  • Pathumtani Hospital
  • Lampang Hospital
  • Surin Hospital
Investigators  ICMJE
Principal Investigator: Boonying Siribumrungwong, MD Ramathibodi Hospital
Study Chair: Ammarin Thakkinstian, PhD Ramathibodi Hospital
Study Chair: Patarawan Woratanarat Ramathibodi Hospital
Study Chair: Borwornsom Leerapan Ramathibodi Hospital
Study Chair: Jittunut Hawanon Thammasat Hospital
PRS Account Ramathibodi Hospital
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP