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.

Not Applicable

Recruiting

• Conditions: Surgical skin grafts; Surgery - Surgical techniques

• Registration Number: ACTRN12609000995279
• Lead Sponsor: Mr Richard Martin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft success at day 5-7 when dressings removed as measured by a standardised wound photograph: Each wound is to be photographed with a scale ruler in place to aid calculation of wound area then mapped with GIMP image processing software to assess percentage of take (defined as the area that is attached to the underlying tissue and viable).[5-7 days from initial skin graft and dressing application. The wound is only assessed once during this period.]

Secondary Outcome Measures

Name	Time	Method
Graft success at follow up clinic in 6 weeks from operation as measured by a standardised wound photograph: Each wound is to be photographed with a scale ruler in place to aid calculation of wound area then mapped with GIMP image processing software to assess percentage of take (defined as the area that is attached to the underlying tissue and viable).[6 weeks from initial skin graft and dressing application.]