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

Surgical Site Infection Clinical Trial

Official title:

Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659983
• Other study ID #: ID 04-55-18 ?
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2012
• Last updated: April 5, 2016
• Start date: November 2012
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Thailand	Vachira hospital	Dusit	Bangkok
Thailand	Chonburi hospital	Meaung	Chonburi
Thailand	Lampang hospital	Meung
Thailand	Pathumtani hospital	Meung	Pathumtani
Thailand	Surin hospital	Meung	Surin
Thailand	Department of Surgery, Ramathibodi Hospital	Rachatevi	Bangkok
Thailand	Thammasat hospital	Rang sit	Patumtani

Sponsors (7)

Lead Sponsor	Collaborator
Ramathibodi Hospital	Chonburi Hospital, Lampang hospital, Pathumtani Hospital, Surin Hospital, Thammasat Hospital, Vachira hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superficial surgical site infection (SSI)	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	within 1 month after operation	No
Secondary	postoperative pain	• Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3	within 3 days after operation	No
Secondary	Quality of life	Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation	1 month after operation	No
Secondary	Cost of treatment	Both direct and indirect costs of treatment will be recorded	1 month after operation	No