Randomised Control Study to Asses the Role of Negative Pressure Wound Therapy (NPWT) in the Management of Wound in Surgical Patient

January 3, 2015 updated by: Sebastian Smolarek, St James Connolly Memorial Hospital

RANDOMISED CONTROL STUDY TO ASSES THE ROLE OF NEGATIVE PRESSURE WOUND THERAPY (NPWT) IN THE MANAGEMENT OF WOUND IN SURGICAL PATIENT

Aim of the study is to assess the role of negative pressure therapy in the prevention of the complication of the laparotomy wound in the high risk patients group.

Primary outcome: Reduction in wound infection rate by 50%

Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound management Decrease cost of patient treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Wound complications are common in general surgical patients after laparotomy. The rate of Surgical Site Infections after elective surgery ranges between 3-30%, depending of the study.

There are subgroups of patients with co-morbid conditions that put them at high risk of wound complications. These co-morbid conditions include increase BMI, known malignancy, diabetes mellitus, emergency surgery, malnutrition, smoking and diffuse atherosclerotic disease involving arteries. Management of these complicated wounds are a significant source of psychological trauma to patients and significantly increases hospital stay and cost.

Since its introduction, Negative Pressure Wound Therapy (NPWT) has been used mainly to deal with chronic wounds. Mechanism of action of NPWT includes protection of wound bed, splinting of soft tissues, reduction of oedema, increasing blood perfusion of wound and enhancing granulation tissue. Application of Negative Pressure Wound Therapy to prevent wound complications is a new concept, which has been successfully applied in acute wounds in orthopaedics, gynecological and cardiothoracic surgery patients.

There is limited data about the use of Negative Pressure Wound Therapy in high risk general surgical patients with acute wounds, but available studies suggest significant reduction in wound complication rate and hospital costs. There is a need for a randomised controlled study to assess the reduction of wound complication ratio.

Patient will be randomized to two groups:

Group 1. Standard wound treatment, Group 2. Treatment with negative pressure wound therapy (NPWT). If a patient is randomized to standard wound treatment group - he/she will receive standard skin closure and standard Mepore dressing, which will be changed on a daily basis.

Patients randomized to negative pressure group will received negative pressure dressing (Pico Wound Management System - manufacture by Smith & Nephew) associated with Acticoat Flex dressing which will be applied immediately after skin closure in a conventional way and left in place for 7 days. Negative pressure dressing will be changed once during 7 days period - after day 2 to 4. Wound complications within first 30 days of surgery will be recorded on clinical examination.

Participants will be recruited from patients undergoing elective and emergency surgery in Connolly Hospital, Beaumont Hospital, St Vincent University Hospital and Mater Misericordiae University Hospital based on inclusion or exclusion criteria.

Inclusion criteria:

  1. One from below:

    • High BMI
    • Malignancy
    • Malnutrition
    • T2 DM
    • Emergency surgery
    • Post radio chemotherapy
    • On steroids
    • Open colorectal resection

  2. At least two from below:

    • Smoking
    • Age>75
    • Diffuse atherosclerotic disease involving arteries

Exclusion criteria:

  • Low risk laparotomy wound (none of the above criteria)
  • Age < 18

Patient who fulfills inclusion criteria will be contacted prior to surgery by a research team member. Details of the study and risks and benefits will be explained to the patient. After obtaining consent the patient will be randomized to one of two groups - standard wound treatment or negative pressure treatment - by senior research team member. depending on the randomisation patient will recived appropriate dressing. Surgical wound will be asses on day 2 to 4, on day 7 and on day 30. Prior to first dressing application, after 2-4 days and on day 30 a wound swap will be obtain for C&S. Any wound complication will be recorded in research evaluation form.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland, 16
        • Recruiting
        • Connolly Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas N Walsh, Prof, M.D, FRCSI
        • Principal Investigator:
          • Michal Kazanowski, M.D
        • Principal Investigator:
          • Sebastian K Smolarek, M.D
        • Sub-Investigator:
          • Mayilone Arumugasamy, M.D, FRCSI

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. One from below:

    • High BMI
    • Malignancy
    • Malnutrition
    • T2 DM
    • Emergency surgery
    • Post radio chemotherapy
    • On steroids
    • Open colorectal resection

  2. At least two from below:

    • Smoking
    • Age>75
    • Diffuse atherosclerotic disease involving arteries

Exclusion Criteria:

  • Low risk laparotomy wound (none of the above criteria)
  • Age < 18

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICO + Acticoat group
Patients randomized to negative pressure group will received negative pressure dressing (Pico Wound Management System - manufacture by Smith & Nephew) associated with Acticoat Flex dressing which will be applied immediately after skin closure in a conventional way and left in place for 7 days. Negative pressure dressing will be changed once during 7 days period - after day 2 to 4. Wound complications within first 30 days of surgery will be recorded on clinical examination.
Device: PICO + Acticoat group
Comparison between Pico and Acticoat dressing change after 3 and 7 days with standard Mepor dressing change on daily basis.
Other Names:
  • PICO
  • Acticoat Flexi 7 dressing
Active Comparator: Standard Wound management
If a patient is randomized to standard wound treatment group - he/she will receive standard skin closure and standard Mepore dressing, which will be changed on a daily basis.
Device: PICO + Acticoat group
Comparison between Pico and Acticoat dressing change after 3 and 7 days with standard Mepor dressing change on daily basis.
Other Names:
  • PICO
  • Acticoat Flexi 7 dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in wound infection by 50%
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of the length of hospital stay
Time Frame: 1 year
1 year
Decrease antibiotics use in a wound infection management
Time Frame: 1 year
1 year
To decrease the cost of patient treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

St James Connolly Memorial Hospital

Investigators

  • Principal Investigator: Sebastian K Smolarek, M.D, Connolly Hospital/Mater Misericordiae University Hospital
  • Study Chair: Thomas N Walsh, Professor, M.D, FRCSI, Connolly Hospital, Royal College of Surgeons in Ireland

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

August 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPWT Ireland

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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