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

NCT01531543 | Completed Phase 4

• 1 other identifier: BuloVAC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Peritonitis

Keywords

Vacuum Assisted Closure (VAC); Laparostomy; Severe peritonitis

Outcome Measures

Primary Outcomes (1)

• Mortality

  The proportion of survivors and died patients

  60 days after surgery

Secondary Outcomes (2)

• Surgical Site Infection rate

  30 days after surgery

• Length of stay

  duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

VAC-laparostomy

EXPERIMENTAL

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 abdominal closure

NO INTERVENTION

The abdominal wall is primary closed after the surgical revision because of severe peritonitis

Interventions

V.A.C.- Vacuum assisted closure laparostomy (KCI) DEVICE

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.

Also known as: Vacuum Assisted Closure (V.A.C.) - KCI, USA

VAC-laparostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Faculty Hospital Na Bulovce: lead

Study Sites (1)

Faculty Hospital Bulovka

Prague, 18081, Czechia

Location

MeSH Terms

Conditions

Peritonitis

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Ondrej Ryska, MD

  Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ICU - Department of Surgery, Principal Investigator

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 13, 2012
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

CZ (1)