A prospective randomized control trial comparing a non adherent dry dressing with a silver foam dressing in the management of Kirscher wire (K-wire) pin sites in the closed fractures of the hand.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001023246

Enrollment

120

Registered

2009-11-25

Start date

2010-01-01

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

This study looks at two types of surgical wound dressing used after fixing fractures of the hand with a pin called a K-wire and whether there is a difference in infection rates and the ease of , and pain associated with, application and removal. When a person fractures a bone they may have a closed fracture or an open or compound fracture. A closed fracture is when the broken bone does not penetrate the skin. In this study, we are only looking at patients with closed fractures. In addition, for inclusion in this study, the fracture must be of the hand higher (distal) than the wrist crease. The Kirscher Wire Pin (commonly known as a K-wire) is a sharpened, sterilised metal pin that is used to hold the fractured bone fragments together. After insertion of the K-wire, the wound is dressed and then assessed on a weekly basis for infection. Infection is common (about 10% of cases) because the insertion of the wire through the skin into the bone creates a passage for bacteria. The area around the wire may become red and swollen and there may be a discharge. Antibiotics may have to be prescribed and sometimes the pin needs to be removed prematurely. Current practice involves dressing the wound in Melolin – a dry non-adherent sterile dressing and Mefix – a surgical tape. In this study we would like to compare this dressing with a new anti-microbial barrier dressing which contain nanocrystalline silver. This type of silver has long been known for its antimicrobial properties. The patients would be consented prior to surgery and then randomly allocated one of the two wound dressings. For both arms of the study, the patients will be followed up and assessed in exactly the same manner. If a patient does not wish to participate in the trial the wound will be dressed in the dry dressing as is current practice.

Interventions

The K-wire is inserted as per normal surgical practice. The wound is dressed using the dry dressing. As per standard clinical practice - the patient attends outpatients weekly for up to 8 weeks The dressing is assessed at each appointment as to whether it needs changing. .K-wire removal usually occurring after 4 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

Closed fractures of the hand distal to the wrist crease

Exclusion criteria

Open fractures

Outcome results