Post-operative wound management

ISRCTN	ISRCTN92903493
DOI	https://doi.org/10.1186/ISRCTN92903493
Secondary identifying numbers	12054

Submission date: 05/09/2012
Registration date: 10/09/2012
Last edited: 16/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mr Suheer Karlakki
Scientific

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

Phone	+44 1691 404344
Email	sudheer.karlakki@rjah.nhs.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of a postoperative wound management protocol using negative pressure wound therapy in primary arthroplasty patients
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(s)	First MREC, 18 May 2012, ref: 12/SW/0094
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
Primary outcome measure	To introduce a new post-operative wound management protocol based on using PICO NPWT.
Secondary outcome measures	No secondary outcome measures
Overall study start date	16/08/2012
Overall study end date	16/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 220
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 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

England
United Kingdom

Study participating centre

Robert Jones & Agnes Hunt Orthopaedic & District Hospital

Oswestry
SY10 7AG
United Kingdom

Sponsor information

Robert Jones & Agnes Hunt Orthopaedic & District Hospital
Hospital/treatment centre

Twmpath Lane
Oswestry
SY10 7AG
England
United Kingdom

Website	http://www.rjah.nhs.uk/
"ROR"	https://ror.org/030mbcp39

Funders

Funder type

Industry

Smith & Nephew Medical Ltd

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No

Editorial Notes

16/04/2018: Publication reference added.
10/03/2016: No publications found, verifying study status with principal investigator.