Table 1 Summary of clinical evidence for the 3MTM Study reference


Title


Moffatt CJ, Edwards L, Collier M, et al. Int Wound J 2008; 5(2): 267-795


A randomised eight-week crossover clinical evaluation of the 3MTM


CobanTM 2


Compression System versus ProforeTM


to evaluate the


product performance in patients with venous leg ulcers


CobanTM


2 Compression System Type


RCT, eight-week crossover design; 81 patients


Purpose


To compare systems for slippage, health- related quality of life, patient preference and wound healing


Hampton S, Kerr A, Crossley M. Data on file. 3M, 200624


Summary of five case studies on the treatment of venous leg ulcers with a new two layer compression system in a community setting


Case study series following five patients for six weeks


To evaluate clinical acceptability and product performance (slippage and wear time) of 3MTM CobanTM


2


Jünger M, Hasse H, Ladwig A, et al. Data on file. 3M, 20102


Compression therapy in patients with peripheral arterial occlusive disease: A prospective clinical study with the 3MTM


CobanTM 2


Layer Lite Compression System for ABPI≥0.5


Bain G. Data on file. 3M, 200825


Evaluation of new bandage system to improve wound healing outcomes for patients with problematic venous leg ulcers


Case study series of eight patients; patients were assessed weekly for four weeks


Single-centre, open label study of 15 patients with ABPI of 0.5–0.8


To assess safety and tolerability of 3MTM CobanTM


Outcomes n


n


There was significantly less slippage after 3–7 days with 3MTM


CobanTM 2 (p<0.0001)


No significant difference in % wounds that healed or in wound area reduction between the different compression systems


n 72% of patients preferred 3MTM Profore


n


n 3MTM n


n CobanTM CobanTM 2 over


Patient preference was similar regardless of randomisation order


2 was easy to learn and easy to apply


The system conformed well to a variety of limb shapes


The system was found to be aesthetically pleasing and demonstrated seven-day wear time on the majority of patients (minimum wear time four days)


n


The system was never changed as a result of slippage or sagging


n 3MTM n 2 Lite


in patients with impaired arterial circulation (ABPI 0.5–0.8)


To measure healing for patients whose venous leg ulcers had not responded to conventional compression bandaging


McGuiness B, Rice J. Data on file. 3M, 20083


Understanding the clinical and patient outcomes of new bandaging system: summary of four case studies


Case study series of four patients; patients were assessed weekly


To


understand effect of dressings on clinical and patient outcomes


Hayes W, Day J. J Wound Care 2007; 3M (Suppl): 1-124


Evaluating a new and unique two-layer compression system for patients with venous leg ulceration


Case study series of four patients; patients were assessed weekly for six weeks


To evaluate clinical acceptance (bandage slippage and wear time), in venous leg ulcer patients treated with 3MTM CobanTM


2


Healthcare practitioners are advised to consult the manufacturer’s instructions before applying any dressing. Supported by an educational grant from 3M. The views expressed in this ‘Made Easy’ section do not necessarily reflect those of 3M.


n CobanTM 2 Lite was safe and well tolerated by patients with ABPI 0.5-0.8


Average supine sub-bandage pressure was 28mmHg immediately after bandage application


No pressure-related skin damage occurred and no pain related to tissue hypoxia was reported


n 3MTM n 3MTM CobanTM 2 Lite demonstrated beneficial effects


on the microcirculation CobanTM


n 2 obtained faster reduction in oedema,


pain and exudation than the traditional multi-layer compression systems used previously


A 30-40% reduction in wound surface area was observed in 6 patients over the four-week trial period; one patient’s ulcer was healed by the 6th weekly visit, after two years of non-healing


n


Minimal bandage bulk allowed patients to wear normal shoes


n 3MTM n CobanTM by all patients


The persistent leg ulcers of two patients healed within the four-week evaluation period


n


In all cases, considerable oedema reduction was achieved


n 3MTM n CobanTM 2 provided effective therapeutic levels of compression that patients could tolerate


In all cases, wound dimensions reduced during the six-week evaluation period


n


Patients were able to wear their choice of clothing and footwear


n


All patients experienced improved comfort levels and were concordant with treatment


2 was comfortable and well tolerated


S.5


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