Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
NCT ID: NCT01659983
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2012-11-30
2016-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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 Criteria
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Inclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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Thammasat Hospital
UNKNOWN
Chonburi hospital
OTHER_GOV
Vachira hospital
UNKNOWN
Pathumtani Hospital
UNKNOWN
Lampang Hospital
OTHER
Surin Hospital
UNKNOWN
Ramathibodi Hospital
OTHER
Responsible Party
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Boonying Siribumrungwong
Section for Clinical Epidemiology and Biostatistics
Principal Investigators
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Boonying Siribumrungwong, MD
Role: PRINCIPAL_INVESTIGATOR
Ramathibodi Hospital
Ammarin Thakkinstian, PhD
Role: STUDY_CHAIR
Ramathibodi Hospital
Patarawan Woratanarat
Role: STUDY_CHAIR
Ramathibodi Hospital
Borwornsom Leerapan
Role: STUDY_CHAIR
Ramathibodi Hospital
Jittunut Hawanon
Role: STUDY_CHAIR
Thammasat Hospital
Locations
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Vachira hospital
Dusit, Bangkok, Thailand
Department of Surgery, Ramathibodi Hospital
Rachatevi, Bangkok, Thailand
Chonburi hospital
Meaung, Changwat Chon Buri, Thailand
Surin hospital
Meung, Changwat Surin, Thailand
Pathumtani hospital
Meung, Pathumtani, Thailand
Thammasat hospital
Rangsit City Municipality, Patumtani, Thailand
Lampang hospital
Meung, , Thailand
Countries
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References
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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.
Other Identifiers
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ID 04-55-18 ว
Identifier Type: -
Identifier Source: org_study_id
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