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Clinical trial report - assessment

Trial Assessment

  • Photography: - From the digital photographs wound area was assessed at each time point.

  • Exudate: - The clinician assessed levels of wound exudate at each visit. The exudate level was scored on a scale of 1 for no exudate up to 10 for high levels of exudate.

  • Pain: - The clinician assessed levels of pain at each visit. The pain was scored on a scale of 1 for no pain up to 10 for extreme/unbearable pain.

  • Infection: - Swabs of the wounds were not carried out, however, general observations of any colonisation of the wounds were made and noted.

  • General observations of wound: - The wound surface and surrounding skin was observed and a description noted of general characteristics, e.g. slough, granulation, colour, level of inflammation etc.

  • Report

  • Results

  • Conclusions

  • Case Study 1

  • Case Study 2

  • Case Study 3

 

Ultrasound Scanning:

This technique was included in the study because of the additional quantitative information it could yield.

The benefit of including ultrasound as an assessment tool is that it provides information about what is happening beneath the wound surface, i.e. the wound bed where healing is initiated. Also it allows us to investigate what is happening in and beneath the intact periwound skin.

Combining this information with that gained from the above techniques which look at surface characteristics we can get the whole picture of what's happening.

The scanner used in this project operated at a frequency of 20MHz (Episcan - Longport Inc.).

This frequency gives an axial resolution of 65μm. The scanning procedure required each volunteer to sit in a chair. The wound was exposed and an aqueous gel applied to the wound and also the surrounding intact skin.

Scans were then taken in these two regions

Scan positions

Figure 1:

Photograph indicating typical regions where scans were made.
Scans were also taken of the patients normal skin remote from the wound site to get a profile of what the patients uninjured skin should look like.
Using the scanners image analysis software it was possible to measure the amount of oedema within the wound and surrounding tissue.

Scan positions

Figure 2:

Scans of these two areas in and around the wound were then compared to the scans of the 'normal' skin (fig 2) to give us a measure of how far from normal the tissues were at the start of the study and how they then progressed back towards the normal profile as the study advanced.