Clinical trial NCT01659983: Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Official title: Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Keywords: complicated appendicitis
wound closure
infection
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Thammasat Hospital
name: Chonburi hospital
name: Vachira hospital
name: Pathumtani Hospital
name: Lampang Hospital
name: Surin Hospital
First posted: 2012-08-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Superficial surgical site infection (SSI)
timeFrame: within 1 month after operation
Secondary outcomes:
measure: postoperative pain
timeFrame: within 3 days after operation
measure: Quality of life
timeFrame: 1 month after operation
measure: Cost of treatment
timeFrame: 1 month after operation
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Vachira hospital
state: Bangkok
city: Rachatevi
country: Thailand
facility: Department of Surgery, Ramathibodi Hospital
state: Bangkok
city: Meaung
country: Thailand
facility: Chonburi hospital
state: Chonburi
city: Meung
country: Thailand
facility: Pathumtani hospital
state: Pathumtani
city: Rang sit
country: Thailand
facility: Thammasat hospital
state: Patumtani
city: Meung
country: Thailand
facility: Surin hospital
state: Surin
city: Meung
country: Thailand
facility: Lampang hospital
Study officials:
affiliation: Ramathibodi Hospital
name: Boonying Siribumrungwong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital
name: Ammarin Thakkinstian, PhD
role: STUDY_CHAIR
affiliation: Ramathibodi Hospital
name: Patarawan Woratanarat
role: STUDY_CHAIR
affiliation: Ramathibodi Hospital
name: Borwornsom Leerapan
role: STUDY_CHAIR
affiliation: Thammasat Hospital
name: Jittunut Hawanon
role: STUDY_CHAIR
References:
citation: 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.