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