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

Study Overview
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Brief Summary
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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

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Procedure: Primary wound closure


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult patients age 18 years or older 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 Non-immunocompromised hosts which include AIDS History of end-stage renal disease (ESRD) History of autoimmune disease (SLE) Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil) Cirrhosis with ascites Morbid obesity (BMI > 40 kg/m2) Non-pregnant women Willing to participate and provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary wound closure<br>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. | Procedure: Primary wound closure<br>* 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.<br>|
| Active Comparator: Delayed primary wound closure<br>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 | Procedure: Primary wound closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Cost of treatment | Both direct and indirect costs of treatment will be recorded | 1 month after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complicated appendicitis, wound closure, infection