Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
NCT01659983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2016-04-06
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
Conditions
- Surgical Site Infection
Interventions
- 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.
Sponsors & Collaborators
-
Thammasat Hospital
collaborator UNKNOWN -
Chonburi hospital
collaborator OTHER_GOV -
Vachira hospital
collaborator UNKNOWN -
Pathumtani Hospital
collaborator UNKNOWN -
Lampang Hospital
collaborator OTHER -
Surin Hospital
collaborator UNKNOWN -
Ramathibodi Hospital
lead OTHER
Principal Investigators
-
Boonying Siribumrungwong, MD · Ramathibodi Hospital
-
Ammarin Thakkinstian, PhD · Ramathibodi Hospital
-
Patarawan Woratanarat · Ramathibodi Hospital
-
Borwornsom Leerapan · Ramathibodi Hospital
-
Jittunut Hawanon · Thammasat Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- Thailand
Study Locations
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