NCT02238964 - Reinforcement of Closure of Stoma Site | Biotech Hunter

Enrollment

790

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2017

Study Completion Date

May 18, 2018

Conditions

Hernia

Interventions

DEVICE

Strattice™ Reconstructive Tissue Matrix

The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.

PROCEDURE

Standard Closure

The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.

Trial Locations (35)

Unknown

Hvidovre Hospital, Copenhagen

Academisch Medisch Centrum, Amsterdam

Tameside General Hospital, Ashton-under-Lyne

Royal United Hospital Bath, Bath

Heart of England NHS Foundation Trust, Birmingham

Queen Elizabeth Hospital, Birmingham

Sandwell General Hospital, Birmingham

Pilgrim Hospital, Boston

Bristol Royal Infirmary, Bristol

Broomfield Hospital, Chelmsford

St Peters Hospital, Chertsey

Chesterfield Royal Hospital, Chesterfield

Western Sussex Hospitals NHS Foundation Trust, Chichester

University Hospital Coventry, Coventry

Doncaster Royal Infirmary, Doncaster

Dorset Country Hospital, Dorchester

James Paget University Hospital, Great Yarmouth

St Marks Hospital, Harrow

Raigmore Hospital, Inverness

University Hospitals of Leicester NHS Trust, Leicester

Macclesfield District General Hospital, Macclesfield

Queen Elizabeth the Queen Mother Hospital, Margate

Norfolk & Norwich University Hospital, Norwich

Queens Medical Centre, Nottingham

Salisbury District Hospital, Salisbury

University Hospital of North Tees, Stockton-on-Tees

Royal Stoke University Hospital, Stoke-on-Trent

Kings Mill Hospital, Sutton in Ashfield

Manor Hospital, Walsall

Royal Albert Edward Infirmary, Wigan

New Cross Hosptial, Wolverhampton

Worcestershire Royal Hospital, Worcester

Wythenshawe Hosptial, Wythenshawe

Yeovil District Hospital, Yeovil

York Hospital, York