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

April 5, 2016 updated by: Boonying Siribumrungwong, Ramathibodi Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Meung, Thailand
        • Lampang Hospital
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Vachira hospital
      • Rachatevi, Bangkok, Thailand, 10400
        • Department of Surgery, Ramathibodi Hospital
    • Chonburi
      • Meaung, Chonburi, Thailand, 20000
        • Chonburi Hospital
    • Pathumtani
      • Meung, Pathumtani, Thailand, 12110
        • Pathumtani hospital
    • Patumtani
      • Rang sit, Patumtani, Thailand, 12120
        • Thammasat Hospital
    • Surin
      • Meung, Surin, Thailand
        • Surin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Delayed 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial surgical site infection (SSI)
Time Frame: 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
within 1 month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: within 3 days after operation
• 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
Time Frame: 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
1 month after operation
Cost of treatment
Time Frame: 1 month after operation
Both direct and indirect costs of treatment will be recorded
1 month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Collaborators

Surin Hospital
Chonburi Hospital
Thammasat Hospital
Vachira hospital
Pathumtani Hospital
Lampang Hospital

Investigators

  • Principal Investigator: Boonying Siribumrungwong, MD, Ramathibodi Hospital
  • Study Chair: Ammarin Thakkinstian, PhD, Ramathibodi Hospital
  • Study Chair: Patarawan Woratanarat, Ramathibodi Hospital
  • Study Chair: Borwornsom Leerapan, Ramathibodi Hospital
  • Study Chair: Jittunut Hawanon, Thammasat Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 04-55-18 ว

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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