Post-operative wound management
| ISRCTN | ISRCTN92903493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92903493 |
| Protocol serial number | 12054 |
| Sponsor | Robert Jones & Agnes Hunt Orthopaedic & District Hospital |
| Funder | Smith & Nephew Medical Ltd |
- 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 of protocol
Not provided at time of registration
Contact information
Mr Suheer Karlakki
Scientific
Scientific
Robert Jones & Agnes Hunt Orthopaedic & District Hospital
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
| Phone | +44 1691 404344 |
|---|---|
| sudheer.karlakki@rjah.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of a postoperative wound management protocol using negative pressure wound therapy in primary arthroplasty patients |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
To introduce a new post-operative wound management protocol based on using PICO NPWT. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 16/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/08/2012 |
| Date of final enrolment | 16/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Robert Jones & Agnes Hunt Orthopaedic & District Hospital
Oswestry
SY10 7AG
United Kingdom
SY10 7AG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/04/2018: Publication reference added.
10/03/2016: No publications found, verifying study status with principal investigator.
