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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ramathibodi Hospital
Sponsor:
Collaborators:
Thammasat Hospital
Chonburi Hospital
Vachira hospital
Pathumtani Hospital
Lampang hospital
Surin Hospital
Information provided by (Responsible Party):
Boonying Siribumrungwong, Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01659983
First received: June 25, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Surgical Site Infection
Procedure: Primary wound closure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • Superficial surgical site infection (SSI) [ Time Frame: within 1 month after operation ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • postoperative pain [ Time Frame: within 3 days after operation ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Both direct and indirect costs of treatment will be recorded


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659983

Contacts
Contact: Boonying Siribumrungwong, MD 6622011269 booon_ying@yahoo.com
Contact: Ammarin Thakkinstian, Ph.D 6622011762 raatk@mahidol.ac.th

Locations
Thailand
Vachira hospital Recruiting
Dusit, Bangkok, Thailand, 10300
Contact: Suphakarn Techapongsatorn, MD         
Principal Investigator: Suphakarn Techapongstorn, MD         
Department of Surgery, Ramathibodi Hospital Recruiting
Rachatevi, Bangkok, Thailand, 10400
Principal Investigator: Chumpon Wilasrusmee, MD         
Chonburi hospital Recruiting
Meaung, Chonburi, Thailand, 20000
Contact: Pinot Noorit, mD         
Principal Investigator: Pinit Noorit, MD         
Pathumtani hospital Recruiting
Meung, Pathumtani, Thailand, 12110
Contact: Pratya Chotiya, MD         
Principal Investigator: Pratya Chotiya, MD         
Thammasat hospital Recruiting
Rang sit, Patumtani, Thailand, 12120
Contact: Boonying Siribunrungwong, MD       Boonying22@gmail.com   
Principal Investigator: Boonying Siribunrungwong, MD         
Surin hospital Recruiting
Meung, Surin, Thailand
Principal Investigator: Winai Unpinitpong, MD         
Lampang hospital Recruiting
Meung, Thailand
Principal Investigator: Anuwat Chanthip, MD         
Sponsors and Collaborators
Ramathibodi Hospital
Thammasat Hospital
Chonburi Hospital
Vachira hospital
Pathumtani Hospital
Lampang hospital
Surin Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Boonying Siribumrungwong, Section for Clinical Epidemiology and Biostatistics, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01659983     History of Changes
Other Study ID Numbers: ID 04-55-18 ว
Study First Received: June 25, 2012
Last Updated: November 4, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
complicated appendicitis
wound closure
infection

Additional relevant MeSH terms:
Appendicitis
Communicable Diseases
Infection
Cecal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Intraabdominal Infections

ClinicalTrials.gov processed this record on November 23, 2014