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

NCT01659983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-04-06

No results posted yet for this study

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

Conditions

  • Surgical Site Infection

Interventions

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.

Sponsors & Collaborators

  • Thammasat Hospital

    collaborator UNKNOWN
  • Chonburi hospital

    collaborator OTHER_GOV
  • Vachira hospital

    collaborator UNKNOWN
  • Pathumtani Hospital

    collaborator UNKNOWN
  • Lampang Hospital

    collaborator OTHER
  • Surin Hospital

    collaborator UNKNOWN
  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Boonying Siribumrungwong, MD · Ramathibodi Hospital

  • Ammarin Thakkinstian, PhD · Ramathibodi Hospital

  • Patarawan Woratanarat · Ramathibodi Hospital

  • Borwornsom Leerapan · Ramathibodi Hospital

  • Jittunut Hawanon · Thammasat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659983 on ClinicalTrials.gov