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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
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
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
Time frame: within 1 month after operation
postoperative pain
• Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
Time frame: within 3 days after operation
Quality of life
Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
Time frame: 1 month after operation
Cost of treatment
Both direct and indirect costs of treatment will be recorded
Time frame: 1 month after operation
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