Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Recent and ongoing studies

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Five studies are summarised in this briefing, involving a total of 28 adults with intertrigo.

The studies included in this briefing are 1 prospective, single-arm cohort study (21 people), 2 case series (total of 5 people) and a 2 case reports (1 person each). Study results and information for these unpublished studies have come from a case studies document produced by the company. Three of the studies have been presented at conferences.

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The evidence base comes from studies involving a small number of people treated with InterDry. Most of the studies evaluating InterDry are case series or case reports that provide low-level evidence. A multicentre feasibility study (Kennedy-Evans et al. 2007) showed substantial improvements in itching or burning, denudement (loss of skin layers), secondary satellite lesions, redness and odour by day 5. This study did not involve a control group, so the treatment effects should be interpreted with caution. All available studies had a short follow-up duration of about 5 days. A longer duration of follow up may be helpful to understand the rates of intertrigo recurrence after treatment with InterDry. There is currently no available comparative evidence for InterDry, so the benefits of the technology over existing management options remains uncertain. Available clinical evidence has come from patients treated in Canada or the US, so results may not be generalisable to the NHS. Well-designed, larger and longer-term comparative UK studies would be helpful to understand the efficacy of InterDry compared with existing management options for intertrigo in the NHS.

Table 1 Summary of selected studies

Vorbeck (2016)
Study size, design and location	Case series involving 3 patients with skin conditions resulting from exposure to excessive moisture in skin folds. US.
Intervention and comparator(s)	InterDry. No comparator.
Key outcomes	Patients in this case series were aged between 41 years and 92 years. Intertrigo was present in the abdominal skin fold or under the breast. Patient 1 was a 92-year-old female with intertrigo under both breasts. InterDry was applied with weekly follow up. Symptom improvement was noted at week 2, with complete resolution at week 3. Patient 2 was a 41-year-old female with intertrigo under abdominal skin fold. Complete resolution of symptoms was noted at week 1 follow up. Patient 3 was a 67-year-old female with candidal intertrigo underneath the abdominal skin fold. There was a marked improvement in symptoms at week-1 follow up and complete resolution at 14-day follow up. Overall, the author concluded that InterDry provided effective moisture management and microbial control. The product was well received by both the patient and staff.
Strengths and limitations	Case series was sponsored by the company and provides low-level evidence. Frequency of dressing changes was unclear. Patients were treated in the US therefore results may not be generalisable to the NHS. The study is only available on the company website.
Hill (2016)
Study size, design and location	Case report of a 66-year-old male with skin fold complications. Canada.
Intervention and comparator(s)	InterDry. No comparator.
Key outcomes	Case report of a 66-year-old, 193-kg male with CHF, a history of COPD, obstructed sleep apnoea, chronic left leg ulcer and morbid obesity who was admitted to hospital for CHF. The patient had begun to experience extreme pain, itching and odour, which had been unsuccessfully treated with creams. Then 7 days after applying InterDry the author reported that redness had resolved, and odour and discomfort had reduced. The patient continued to use InterDry, and at day 17 all symptoms of redness, itching and odour had resolved.
Strengths and limitations	Case report involving 1 patient treated in Canada, representing low-level evidence and limiting generalisability of results to the NHS. Frequency of dressing changes was unclear. The study is only available on the company website.
Patti Haberer (2015)
Study size, design and location	Case report of an 80-year-old female with intertrigo. US.
Intervention and comparator(s)	InterDry. No comparator.
Key outcomes	Patient had the following medical history: obesity (BMI 30.5), bilateral mastectomy, uncontrolled diabetes, hypertension, hyperlipidemia, and dementia. The patient had a mild case of intertrigo (redness and pain) in the right armpit and a severe case of intertrigo (redness, maceration, satellite lesions, denuded skin at the base of the fold, odour and pain) in an abdominal skin fold. The author reported that InterDry quickly and effectively resolved both cases of intertrigo within 5 days. At day 2, the redness and pain in the armpit was resolved. At day 5 the redness, satellite lesions, odour, denuded area and pain in the abdominal skin fold had resolved. Results were presented at the Southeast Region of the WOCN Society Annual Conference, September 2015.
Strengths and limitations	Case report involving 1 patient treated in the US, representing low-level evidence and limiting generalisability of results to the NHS. Case study was sponsored by the company. The author was a clinical consultant for the company and a family member of the patient.
Kennedy-Evans et al. (2007)
Study size, design and location	Prospective, single-arm observational study involving 21 people with intertrigo from 2 long-term care centres. US.
Intervention and comparator(s)	InterDry. No comparator.
Key outcomes	Treatment with InterDry statistically significantly reduced itching or burning by day 3 (p=0.0001) and by day 5 (p<0.0001). The numbers of people with maceration reduced from 10 on day 1 to 1 on day 3 and day 5. Five patients had satellite lesions on day 1. On day 3 and day 5, 1 patient had satellite lesions that were improving. All patients entered the study with erythema. There was a statistically significant reduction in erythema by day 3 and day 5 (both p<0.0001). Separated odour significantly reduced by day 3 (p=0.002) and by day 5 (p=0.0034). Closed odour was not statistically analysed. Presented at the 39th WOCN Society Annual Conference, June 2007.
Strengths and limitations	Single-arm study with no control group, treatment effects may need to be interpreted with caution. It involved a small number of people treated in the US therefore results may not be generalisable to the NHS. There was limited information available on study methodology, outcome reporting, baseline demographics and confidence intervals, making it difficult to assess the overall quality of evidence of the study.
Tessling et al. (2007)
Study size, design and location	Case series involving 2 patients with skin conditions resulting from exposure to excessive moisture. US.
Intervention and comparator(s)	InterDry combined with appropriate topical wound treatment. No comparator.
Key outcomes	Patients in this case series were aged 44 years and 69 years. Patient 1, a 69-year-old male with paraplegia presenting with intertrigo of the interdigital spaces with maceration between toes before intervention. InterDry was applied and changed daily after bathing. Maceration resolved within 3 days of treatment. Patient 2, a 44-year-old male presenting with intertrigo in his armpit, abdominal skin fold and groin folds. The moist skin peeling was improved within 24 hours, with the affected areas completely healed within 1 week. Presented at the 39th WOCN Society Annual Conference, June 2007.
Strengths and limitations	Case study series sponsored by the company and provides low-level evidence. Patients were treated in the US so results may not be generalisable to the NHS. Frequency of dressing changes was only stated for 1 patient.
Abbreviations: BMI, body mass index; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; WOCN, Wound, Ostomy and Continence Nurses Society.

Recent and ongoing studies

No ongoing or in-development trials were identified. The company states that post-marketing surveillance in the UK is ongoing. This includes a market survey on the usability of InterDry and an observational study evaluating its clinical effectiveness and impact on parameters relating to health economics.