The comparison of the disposable Negative Pressure Wound Therapy Device (NPWT) to current standard dressings on medium sized Split Skin Grafts (SSG)

A randomised control trial pilot study for comparison of the single use Negative Pressure Wound Therapy Device (NPWT) to current standard dressings on medium sized Split Skin Grafts (SSG) for emergency and elective surgery cases to assess healing time/quality and of treatment costs

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000702819

Enrollment

Registered

2012-07-02

Start date

2012-07-06

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Negative Pressure Wound therapy (NPWT) has been used in surgery for over 15 years for a whole range of wounds with good outcomes and many advantages to promote wound healing. Recent technological advancements have led to the production of a single use NPWT device designed for small to medium size wounds with low-moderate levels of exudates. Early uses of the dressing in literature have shown through individual case studies the potential use of Pico dressing for skin grafts leading to an earlier discharge date. However, there have been no broader studies of the use of Pico dressing in this specific treatment group. The Pico dressing is a type of single use negative pressure wound therapy produced by company Smith and Nephew. The study has been designed as a randomised control prospective trial. The main hypothesis to be tested is that the use of a single use negative pressure wound therapy with early discharge from hospital will have equal efficacy in wound healing to the current protocol of wound therapy.

Interventions

Application of Single Use, negative pressure wound dressing to medium size (between 50mmx50mm to 100mmx150mm in dimension) split skin graft. Dressing size will be directed by the size of the skin graft required. The dressing will be applied by the treating clinician at time of operation to apply the skin graft, and will take approximately 5-10 minutes to cut to size and apply. It is to remain in place for total duration of 5-7 days (selected on a case by case basis according to patient's needs

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients requiring medium sized split skin grafts between dimensions of 50x50mm to 100x150mm for primary wound closure, recruited as either emergency or elective surgical cases through the Royal Adelaide Hosptial Plastic and Reconstructive Surgery department, fit and able to give informed consent for surgery

Exclusion criteria

Poor compliance/behavioural issues, Patients who live alone in the community, patients who may immeadiately require in the post-operative period MRI/Hyperbaric Chamber and/or Defibrillation, unsuitable graft bed for split skin graft take including presence of nectrotic eschar/exposed vessels/infected wound bed/deep tissue malignancy, uncompensated chronic disease that would affect patient suitability for surgery, patient currently on antiplatelet/anticoagulant medications

Outcome results