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Prospective Comparison of Primary Abdominal Closure and Vacuum Assisted Laparostomy in Treatment of Severe Peritonitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zuzana Serclova, MD, The Faculty Hospital Na Bulovce
ClinicalTrials.gov Identifier:
NCT01531543
First received: February 7, 2012
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The aim of the project was to optimalize the process in severe peritonitis which is generally inflicted with high mortality and morbidity with long term costly therapy. Therapy of severe intraabdominal infection consist of treatment of the infection site and following closure of the abdominal cavity with possibility of re-laparotomy and in treatment of complications when needed; or closure introduction of laparostomy with intention to control complications prevention however with risk of tertiary peritonitis. Modern process is laparostomy with active suction (VAC) method which reduces the risk of tertiary peritonitis. It efficacy is however approved especially in therapy of complications. Based on the investigators experiences the investigators use this method even in case of primary treatment of severe peritonitis which led to protocol processing (VAC in case of primary closure of the abdominal cavity; VAC exchange according to scoring system; secondary closure of the abdominal cavity or early coverage with collagen mesh). The aim of this project is to prove reduced mortality, morbidity and hospitalization length (cost reduction) in prospective randomized study in patients treated due to severe peritonitis using VAC method in comparison to classical approach (primary closure of the abdominal cavity; secondary solution of complications).


Condition Intervention Phase
Peritonitis
Device: V.A.C.- Vacuum assisted closure laparostomy (KCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Primary Use of the Vacuum Assisted Laparostomy in Treatment of Severe Peritonitis

Further study details as provided by The Faculty Hospital Na Bulovce:

Primary Outcome Measures:
  • Mortality [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
    The proportion of survivors and died patients


Secondary Outcome Measures:
  • Surgical Site Infection rate [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Incidence of HAIs during the 60 days after surgery. Diagnosis confirmed using criteria CDC/NHSN

  • Length of stay [ Time Frame: duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    Length of hospital stay (days)


Enrollment: 57
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAC-laparostomy
Primary use of Vacuum Assisted Closure (VAC) laparostomy after surgical revision because of severe peritonitis
Device: V.A.C.- Vacuum assisted closure laparostomy (KCI)
Primary Vacuum Assisted Closure (V.A.C.)laparostomy was indicated after surgery in patients with severe peritonitis. VAC laparostomy was performed using sandwich technique (semi-permeable foil - intraabdominal foam - dynamic sutura of the fascia - foam inserted subcutaneously - non-permeable foil) and connected to the active suction of 125mmHg.
Other Name: Vacuum Assisted Closure (V.A.C.) - KCI, USA
No Intervention: Primary abdominal closure
The abdominal wall is primary closed after the surgical revision because of severe peritonitis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients indicated for urgent surgery for suspected acute abdomen with severe peritonitis (meet SIRS criteria or signs of diffuse peritoneal irritation)
  • the diagnose of severe peritonitis is confirmed intraoperatively (Mannheim Peritonitis Index - MPI > 25)
  • patient agrees with inclusion to the study

Exclusion Criteria:

  • patients aged < 18 and > 80 years
  • patients with not expected survival longer than 48 hours after surgery
  • patients with different peroperative finding
  • primary abdominal closure is not technically possible
  • pregnant or nursing women
  • patient does not agree to participate in the study, self-payers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531543

Locations
Czech Republic
Faculty Hospital Bulovka
Prague, Czech Republic, 18081
Sponsors and Collaborators
The Faculty Hospital Na Bulovce
Investigators
Principal Investigator: Ondrej Ryska, MD Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic
  More Information

No publications provided

Responsible Party: Zuzana Serclova, MD, Head of ICU - Department of Surgery, Principal Investigator, The Faculty Hospital Na Bulovce
ClinicalTrials.gov Identifier: NCT01531543     History of Changes
Other Study ID Numbers: BuloVAC
Study First Received: February 7, 2012
Last Updated: February 10, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by The Faculty Hospital Na Bulovce:
Vacuum Assisted Closure (VAC)
Laparostomy
Severe peritonitis

Additional relevant MeSH terms:
Peritonitis
Digestive System Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases

ClinicalTrials.gov processed this record on November 24, 2014