Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

Summary

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.

NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.

In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Conditions

• Surgical Wound
• Wound Dehiscence, Surgical
• Surgical Site Infection
• Dehiscence of Internal Surgical Wound

Interventions

DEVICE

Prophylactic negative pressure wound dressing after laparotomy

Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.

Sponsors & Collaborators

• Semmelweis University

  collaborator OTHER

• Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest

  collaborator UNKNOWN

• Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár

  collaborator UNKNOWN

• Institute of Surgery, University of Debrecen

  collaborator UNKNOWN

• Department of Surgery, University of Szeged

  collaborator UNKNOWN

• Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest

  collaborator UNKNOWN

• Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely

  collaborator UNKNOWN

• Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét

  collaborator UNKNOWN

• Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen

  collaborator UNKNOWN

• Department of Surgery, Szent Rókus Kórház, Baja

  collaborator UNKNOWN

• Department of Surgery, St. Borbala hospital, Tatabanya

  collaborator UNKNOWN

• St. Borbala Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2020-07-01

Completion

2020-09-01

Countries

• Hungary

Study Locations