NCT02331485

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

August 4, 2014

Last Update Submit

January 3, 2015

Conditions

Wound InfectionWound Complication

Keywords

Prevention of wound infection and wound complication

Outcome Measures

Primary Outcomes (1)

  • Reduction in wound infection by 50%

    1 year

Secondary Outcomes (3)

  • Reduction of the length of hospital stay

    1 year

  • Decrease antibiotics use in a wound infection management

    1 year

  • To decrease the cost of patient treatment

    1 year

Study Arms (2)

PICO + Acticoat group

EXPERIMENTAL

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

Standard Wound management

ACTIVE COMPARATOR

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

Interventions

PICO + Acticoat groupDEVICE

Comparison between Pico and Acticoat dressing change after 3 and 7 days with standard Mepor dressing change on daily basis.

Also known as: PICO, Acticoat Flexi 7 dressing
PICO + Acticoat groupStandard Wound management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One from below:
  • High BMI
  • Malignancy
  • Malnutrition
  • T2 DM
  • Emergency surgery
  • Post radio chemotherapy
  • On steroids
  • Open colorectal resection
  • At least two from below:
  • Smoking
  • Age\>75
  • Diffuse atherosclerotic disease involving arteries

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connolly Hospital

Dublin, 16, Ireland

RECRUITING

Related Publications (5)

  • Lewis LS, Convery PA, Bolac CS, Valea FA, Lowery WJ, Havrilesky LJ. Cost of care using prophylactic negative pressure wound vacuum on closed laparotomy incisions. Gynecol Oncol. 2014 Mar;132(3):684-9. doi: 10.1016/j.ygyno.2014.01.014. Epub 2014 Jan 17.

    PMID: 24440649BACKGROUND

  • Ousey KJ, Atkinson RA, Williamson JB, Lui S. Negative pressure wound therapy (NPWT) for spinal wounds: a systematic review. Spine J. 2013 Oct;13(10):1393-405. doi: 10.1016/j.spinee.2013.06.040. Epub 2013 Aug 24.

    PMID: 23981819BACKGROUND

  • Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.

    PMID: 23539123BACKGROUND

  • Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.

    PMID: 23111014BACKGROUND

  • Stoffan AP, Ricca R, Lien C, Quigley S, Linden BC. Use of negative pressure wound therapy for abdominal wounds in neonates and infants. J Pediatr Surg. 2012 Aug;47(8):1555-9. doi: 10.1016/j.jpedsurg.2012.01.014.

    PMID: 22901916BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Sebastian K Smolarek, M.D

    Connolly Hospital/Mater Misericordiae University Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas N Walsh, Professor, M.D, FRCSI

    Connolly Hospital, Royal College of Surgeons in Ireland

    STUDY CHAIR

Central Study Contacts

Sebastian Krzysztof Smolarek, M.D

CONTACT

00353857401990sebastian.smolarek79@gmail.com

Michal Kazanowski, M.D

CONTACT

0035385241368mikazanowski@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

August 4, 2014

First Posted

January 6, 2015

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

IE(1)