Wound Outcomes in Negative Pressure Dressings (WOUNDS) - Suction dressings and mobility compared to conventional dressings and bed rest for healing of split skin grafts of the lower leg.

A prospective randomised control trial of lower leg skin grafts with negative pressure suction dressing and early mobilisation versus conventional dressings for rate of graft success.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000995279

Enrollment

100

Registered

2009-11-17

Start date

2011-01-17

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

We intend to perform a prospective, randomised control trial on whether negative pressure suction dressings and early ambulation are comparable to or improve split skin graft take over conventional bolster dressings for lower leg wounds. The lower leg is a common site for skin grafts, however healing of the skin of the lower leg can be slow leading to graft failure. Traditionally, a bolster dressing (a padded dressing over the graft) and bed rest for at least five days are recommended. Negative pressure dressings (of which the Vacuum Assisted Closure (VAC) system is commonly used internationally and in New Zealand) have been used to assist complex wound healing and graft take. The system generates a negative pressure environment which is shown to improve various factors leading to wound healing. However there is a lack of proof for whether such suction dressings improve healing more than the conventional dressings and bed rest techniques for skin grafts. Our study is designed to determine if negative pressure suction dressings and early ambulation are comparable to or improve split skin graft take over conventional bolster dressings and bed-rest for lower leg skin graft wounds.

Interventions

mobile suction dressing (Vacuum Assisted Closure or VAC device), early mobilisation: The negative pressure dressing will consist of a mobile VAC system, comprising of a dressing and suction tubing on a piece of foam secured on the graft with gelonet and staples. The VAC dressing group will be discharged on the same day and will be only mobilising to bathroom, kitchen and their bedroom. The VAC dressing is kept on for 5 to 7 days and is not disturbed over this period (so it is not reapplied).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

1.Patients with lower leg wounds requiring split skin grafting for primary closure e.g. post planned skin lesion removal or trauma, referred to the two specialist surgeons (Mr H. Hammodat, Mr R. Martin) 2.Willing and able (i.e. not transferred to another hospital for whatever reason) to remain in North Shore Hospital after skin grafting for 5-7 days for graft check and/or return to North Shore Hospital in 5-7 days for graft check and dressing change 3.Fit for surgery and able to give consent for the study

Exclusion criteria

1.Surgical contraindications to grafting / surgery e.g a) poor vascular supply ± venous / arterial insufficiency requiring vascular surgical intervention before grafting can be attempted b)systemic infection – septicaemia 2.Immobility 3.Poor vascular supply to leg: either absent foot pulses OR ankle/brachial blood pressure index < 0.8 OR requires referral to vascular services before grafting 4.Enrolled in another clinical trial. 5.Lack of home support or ability to manage daily activities independently with wound dressing and drain at home. 6.Patients with chronic leg wounds / venous ulcers requiring grafting

Outcome results