Condition category
Surgery
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
10/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Suheer Karlakki

ORCID ID

Contact details

Robert Jones & Agnes Hunt Orthopaedic & District Hospital
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
+44 1691 404344
sudheer.karlakki@rjah.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12054

Study information

Scientific title

Evaluation of a postoperative wound management protocol using negative pressure wound therapy in primary arthroplasty patients

Acronym

Study hypothesis

Most postoperative protocols for patients undergoing primary total hip and knee replacements (arthroplasty) require the patient to have a dry wound before being discharged from hospital. This has recently become more important following the introduction of strict guidelines surrounding the use of heparin (a bloodthinning treatment) to reduce the risk/occurence of postoperative blood clots. Oozing from wound sites following such surgery continues to be a common complication in a large number of patients with a resulting delay in hospital discharge and inconvenience to the patient. This increase in stay incurs extra costs on the various trusts and the NHS. The use of Negative Pressure Wound Therapy (NPWT) is a relative recent idea which has shown very promising results in trauma surgery and other fields of surgery. However, there is very limited literature relating to its efficacy and costeffectiveness in arthroplasty surgery. Arthroplasty patients appear to be the ideal candidate for NPWT. Using the standard method of dressings, patients may require multiple changes of dressing and therefore early exposure of the wound. However, due to the mild to moderate nature of wound oozing in arthroplasty patients, is it thought that a single application of PICO dressing is sufficient for the whole period of wound healing.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12054

Ethics approval

First MREC, 18 May 2012, ref: 12/SW/0094

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal surgery

Intervention

Control group
The control group will receive the standard dressings post-operatively

Study group
The study group will receive PICO negative pressure wound therapy post-operatively for 7 days

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

To introduce a new post-operative wound management protocol based on using PICO NPWT.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

16/08/2012

Overall trial end date

16/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing primary total hip or knee replacement
2. Patients with no contraindications for PICO NPWT or standard postoperative dressings
3. Patients who are over 18 years of age and have given informed consent to participant
4. Male and female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 220

Participant exclusion criteria

1. Patients undergoing revision arthroplasty surgery
2. Patients with a known history of poor compliance with medical treatment
3. Patients with known allergies to either product components (silicone adhesives and polyurethane films (direct
contact with incision), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates)
4. Patients on warfarin therapy (these patients may have an increased exudate and also a prolonged stay in hospital following surgery whilst trying to achieve therapeutic INR (international normalized ratio) levels an indication of how well the patient's blood clots
5. Patients who do not give informed consent to participate in this study

Recruitment start date

16/08/2012

Recruitment end date

16/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Robert Jones & Agnes Hunt Orthopaedic & District Hospital
Oswestry
SY10 7AG
United Kingdom

Sponsor information

Organisation

Robert Jones & Agnes Hunt Orthopaedic & District Hospital

Sponsor details

Twmpath Lane
Oswestry
SY10 7AG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.rjah.nhs.uk/

Funders

Funder type

Industry

Funder name

Smith & Nephew Medical Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/03/2016: No publications found, verifying study status with principal investigator.