Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
1 other identifier
interventional
600
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2012
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
August 8, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 6, 2016
April 1, 2016
3.3 years
June 25, 2012
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Superficial surgical site infection (SSI)
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
within 1 month after operation
Secondary Outcomes (3)
postoperative pain
within 3 days after operation
Quality of life
1 month after operation
Cost of treatment
1 month after operation
Study Arms (2)
Primary wound closure
EXPERIMENTALA 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
ACTIVE COMPARATORA 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
Interventions
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramathibodi Hospitallead
- Thammasat Hospitalcollaborator
- Chonburi hospitalcollaborator
- Vachira hospitalcollaborator
- Pathumtani Hospitalcollaborator
- Lampang Hospitalcollaborator
- Surin Hospitalcollaborator
Study Sites (7)
Vachira hospital
Dusit, Bangkok, 10300, Thailand
Department of Surgery, Ramathibodi Hospital
Rachatevi, Bangkok, 10400, Thailand
Chonburi hospital
Meaung, Changwat Chon Buri, 20000, Thailand
Surin hospital
Meung, Changwat Surin, Thailand
Pathumtani hospital
Meung, Pathumtani, 12110, Thailand
Thammasat hospital
Rangsit City Municipality, Patumtani, 12120, Thailand
Lampang hospital
Meung, Thailand
Related Publications (1)
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.
PMID: 29946346DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section for Clinical Epidemiology and Biostatistics
Study Record Dates
First Submitted
June 25, 2012
First Posted
August 8, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 6, 2016
Record last verified: 2016-04