Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
- Conditions
- Surgical Site Infection
- Interventions
- Procedure: Primary wound closure
- Registration Number
- NCT01659983
- Lead Sponsor
- Ramathibodi Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed primary wound closure Primary wound closure A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation Primary wound closure 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.
- Primary Outcome Measures
Name Time Method Superficial surgical site infection (SSI) 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
- Secondary Outcome Measures
Name Time Method postoperative pain 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 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 1 month after operation Both direct and indirect costs of treatment will be recorded
Trial Locations
- Locations (7)
Department of Surgery, Ramathibodi Hospital
🇹🇭Rachatevi, Bangkok, Thailand
Vachira hospital
🇹🇭Dusit, Bangkok, Thailand
Pathumtani hospital
🇹🇭Meung, Pathumtani, Thailand
Surin hospital
🇹🇭Meung, Surin, Thailand
Chonburi hospital
🇹🇭Meaung, Chonburi, Thailand
Thammasat hospital
🇹🇭Rang sit, Patumtani, Thailand
Lampang hospital
🇹🇭Meung, Thailand