Clinical Trial: Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
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
Detailed Summary:
Sponsor: Ramathibodi Hospital
Current Primary Outcome: Superficial surgical site infection (SSI) [ Time Frame: within 1 month after operation ]
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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- postoperative pain [ Time Frame: within 3 days after operation ]• Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
- Quality of life [ Time Frame: 1 month after operation ]Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
- Cost of treatment [ Time Frame: 1 month after operation ]Both direct and indirect costs of treatment will be recorded
Original Secondary Outcome: Same as current
Information By: Ramathibodi Hospital
Dates:
Date Received: June 25, 2012
Date Started: November 2012
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016