Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Procedure: Primary wound closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01659983

ID 04-55-18 ว

Details and patient eligibility

About

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

Enrollment: 600 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Adult patients age 18 years or older

2. Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions

   a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus

3. Non-immunocompromised hosts which include

   1. AIDS
   2. History of end-stage renal disease (ESRD)
   3. History of autoimmune disease (SLE)
   4. Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
   5. Cirrhosis with ascites
   6. Morbid obesity (BMI > 40 kg/m2)

4. Non-pregnant women

5. Willing to participate and provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Primary wound closure

Experimental group

Description:

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.

Treatment:

Procedure: Primary wound closure

Delayed primary wound closure

Active Comparator group

Description:

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

Treatment:

Procedure: Primary wound closure