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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659983

Enrollment

600

Registered

2012-08-08

Start date

2012-11-30

Completion date

2016-03-31

Last updated

2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

complicated appendicitis, wound closure, infection

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

Interventions

PROCEDUREPrimary 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026