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A Randomized Crossover Investigation of Pain at Dressing Change Comparing 2 Foam Dressings

INTRODUCTION:

Pain at dressing change is the result of several factors including trauma and skin stripping caused by the repeated removal of adhesive dressings.To evaluate pain during dressing changes comparing a soft silicone foam dressing = with an acrylic adhesive polyurethane foam dressing.

 

Keywordssoft silicone foam dressing, acrylic adhesive polyurethane foam dressing,pain, periwound maceration.

 

CASE

 

The study was designed as an open, randomized, crossover investigation involving 2 outpatient ambulatory wound care clinics and 1 acute care hospital. A total of 5 visits—1 baseline visit (visit 1) and 4 follow-up visits (visits 2 to 5)—during a maximum period of 30 days were scheduled for each patient. The study was approved by the ethics review boards at the participating institutions.

 

The ulcer must be at least 1 cm2 in size with low to moderate amount of exudate (the previous dressing should be stained but not completely soaked with exudate). The inclusion and exclusion criteria are presented in Table 1.

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Pain Intensity

 

Pain was measured with a visual analog scale and the Short-Form McGill Pain Questionnaire. The characteristics of the wound and the occurrence of adverse events were documented at each scheduled visit.

 

This analysis was based on the change in pain from beforedressing-change baseline to dressing removal, comparing the 2 dressings. Overall, the mean change in pain from before dressing change to dressing removal was nonsignificantly.lower (P = .37) for patients treated with the silicone foam (mean, 0.0; SD, 1.6), compared with an adhesive foam (mean, 0.5; SD, 2.1), with a mean difference of  0.3 (95% confidence interval,  0.4 to 1.0). The comparative VAS scores were significantly lower before dressing change and at dressing removal for patients treated with the silicone foam than for those treated with adhesive foam at both follow-up visits (Table 3).

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Wound Characteristics

 

Differences between the 2 dressings in terms of wound status were observed at the second follow-up visit: wounds treated with silicone foam were associated with a lower proportion of necrotic tissue or slough (P = .0123) and greater proportion of new epithelialization (P = .0110) than those treated with adhesive foam (Table 4).

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RESULTS: A total of 32 patients entered into the study, and 26 patients completed all 5 follow-up study visits. Results indicated lower levels of pain at dressing removal and less periwound maceration in patients who were randomized to the silicone dressings.

 

DISCUSSION

 

Both foam dressings (soft silicone foam and hydrocellular adhesive) compared in this study have advanced absorption and moisture balance wound properties appropriate for use in exudating chronic wounds. The experienced chronic wound-associated pain intensity was different between the 2 dressing classes. This may be due to the characteristics of the foam in contact with the wound surface, the lack of wound adhesion for a soft silicone compared with an acrylic adhesive, or a combination of both components.

 

The VAS pain intensity scores reported before dressing change were significantly and consistently lower in patients treated with Mepilex Border compared with Allevyn Adhesive at the first and second follow-up visits (P = .0007 and P = .018, respectively). The scores reported at dressing removal were also significantly lower in subjects treated with the silicone foam at both follow-up visits (P = .0009 at the first follow-up visit and P = .024 at the second follow-up visit). This is consistent with previous research findings where the silicone foam required a lower peel force and is likely to confer less pain at removal.

 

Pain is an unpleasant emotional experience. The difference in pain intensity is probably due to the atraumatic nature of dressings with soft silicone technology. Dressings such as silicone foams do not adversely adhere or cause trauma either to newly formed tissues in the wound bed or to the periwound skin during wear and on removal. By selecting the least traumatic dressings or adhesives, clinicians may be able to improve pain management in this population.

 

There was significantly more maceration of the periwound skin observed at both follow-up visits during treatment with hydrocellular adhesive foam, compared with soft silicone foam (P = .039 at the first follow-up visit and P = .0030 at the second follow-up visit; Figure 1). The soft silicone foam is lined with a silicone contact layer that seals the periwound skin around the wound bed, forcing the exudate to pass into the absorbent pad, thereby preventing exudate from leaking laterally onto the surrounding skin. When drainage volume exceeds the fluidhandling capacity of a dressing, enzyme-rich and caustic exudate may spill over to wound margins, causing maceration or periwound epidermal erosions (loss of part of the epidermis but maintaining an epidermal base) and pain.The excellent fluid-handling capacity of the soft silicone dressing not only minimizes both maceration of the periwound skin but also reduces contact irritant dermatitis from the corrosive exudate. This may also explain why patients experienced less pain with this dressing.

 

The results of the study must be interpreted with caution. First, the sample size was small, which may have increased the probability of a type I error by concluding that 1 dressing was

better than the other when there was none. Second, only patients with leg ulcers were recruited; thus, study results may not represent an accurate generalization for other patients with a different subtype of chronic wounds. Third, the time frame for this study was relatively short compared with the usual time for ulcers to heal. Fourth, the wound and dressing evaluations

potentially may be swayed by subjectivity and bias as blinding was not incorporated. Finally, the secondary outcomes from the evaluation of the wound characteristics and dressings were

not documented with validated instruments.

 

CONCLUSIONS: 

Chronic wound-related pain is a major problem for patientsand clinicians. For both therapeutic and humanitarian reasons,it is important that investigators assess and manage woundrelated pain. Most important, the choice of appropriate wound-specific dressings and cleansing materials will improve a patients ability to cope with the unpleasant dressing procedures. In this respect, the ability of a soft silicone border dressing to minimize pain together with its high comfort rating provides wound care clinicians with an advantageous dressing choice.

 

Woo, Kevin Y, et al. "A randomized crossover investigation of pain at dressing change comparing 2 foam dressings." Advances in Skin & Wound Care 22.7 (2009): 304-310.


Home> Application literature> A Randomized Crossover Investigation of Pain at Dressing Change Comparing 2 Foam Dressings
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