NCT01659983

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-08-08
• Last updated: 2016-04-06

Locations

7 sites across 1 country: Thailand