Controlled trial of occlusive dressings in healing chronic venous ulcers. Combination of hydrocolloid dressing and medical compression stockings versus Unna's boot for the treatment of venous leg ulcers. A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers. Comparison of two occlusive bandages in the treatment of venous leg ulcers. Prospective, multicenter study of managing lower extremity venous ulcers. A comparison of two dressings in the management of chronic wounds. Randomized trial comparing cryopreserved cultured epidermal allografts with hydrocolloid dressings in healing chronic venous ulcers. Use of a hydrocapillary dressing in the management of highly exuding ulcers: a comparative study. Controlled, randomized clinical trial of 2 hydrocolloid dressings in the management of venous insufficiency ulcers. Use of a fibrous dressing in exuding leg ulcers. Prospective randomized controlled study of Hydrofiber dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. Prospective evaluation of occlusive hydrocolloid dressing versus conventional gauze dressing regarding the healing effect after abdominal operations: randomized controlled trial. The influence of dressings on venous ulcer healing--a randomised trial. Monitoring the microcirculation to evaluate dressing performance in patients with venous leg ulcers. Randomized trial of two foam dressings in the management of chronic venous ulceration.
Fifty-six patients with chronic venous ulcers present for a mean of 2.4 years were randomized to either a new occlusive hydrocolloid dressing (Granuflex, Squibb Surgicare) or a porous non-adherent dressing (N A, Johnson and Johnson). In all patients, dressings were applied beneath a standard graduated compression bandage. There was no difference between the two groups, with complete healing in 21 out of 28 (75 per cent) of occlusive dressing patients and 22 out of 28 (78 per cent) with N A dressings by 12 weeks. Careful graduated compression bandaging achieves healing even in the majority of so-called resistant chronic venous ulcers; there was no additional benefit from applying occlusive dressings which tend to be expensive. Various therapeutic approaches have been developed to manage venous ulcers. In this study the effectiveness of a hydrocolloid dressing (Comfeel Ulcer Dressing) in comparison to the Unna boot, the prototype of rigid bandages, was evaluated.
                Design: Prospective, comparative study.
                University hospital.
                Sixty patients diagnosed with post-thrombotic chronic venous insufficiency with venous ulcers were randomly assigned to two groups of 30 patients. Interventions: In group A, the Unna boot, and in group B, hydrocolloid dressing in addition to the elastic compression were used. Measures: The two groups were compared in terms of 1) complete healing, 2) weekly wound surface reduction, 3) time to complete healing, 4) performance characteristics (ease-of-use score), 5) pain during application and at home, 6) application time.
                The duration of the ulcers was 16.6 +/- 5.8 weeks in group A and 16.9 +/- 6.2 in group B (p >0.05). Previous ulcer recurrence was 74% (20/27 patients) in group A and 73% (19/26 patients) in group B (p >0.05). The initial ulcer size was 6.38 +/- 1.2 cm2 in group A and 6.19 +/- 0.8 cm2 in group B (p >0.05). The complete healing rates were 74.07% (20/27) in group A and 80. 76% (21/26) in group B (p >0.05). The weekly wound surface reductions were 1.28 +/- 0.72 cm2/week and 1.16 +/- 0.38 cm2/week in groups A and B, respectively (p >0.05). The ulcer healing time was 6.85 +/- 3.60 weeks in group A, whereas it was 6.65 +/- 3.31 weeks in group B (p >0.05). Ease-of-use score was 9.04 +/- 2.38 in group A and 17.27 +/- 3.27 in group B and the difference was significant (p <0.0001). A higher degree of pain was reported by the patients who were treated with the Unna boot, both during application (group A 3.69 +/- 1.35, group B 1.88 +/- 1.48, p <0.0001) and at home (group A, 3.27 +/- 1.08, group B, 1.88 +/- 1.11, p <0.0001). The average time spent on Unna boot changes was 150.59 +/- 34.73 min, compared to 134.54 +/- 43.39 min in group B (p >0.05).
                These results demonstrate the superiority of hydrocolloid dressing plus elastic compression treatment in terms of patient convenience. We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration.
                A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat.
                There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0).
                Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings. A randomized controlled study was performed in 34 patients with venous leg ulcers. No difference was found in the healing rate between a new hydrocolloid dressing plus compression, and a double layer bandage, consisting of an inner paste bandage (i.e. a stocking impregnated with zinc oxide paste) and an outer elastic bandage. The parameters chosen for objective evaluation were stereophotogrammetric measurement of ulcer area and volume, and bacterial counts. Seventy patients with 90 venous ulcers were randomly assigned to hydrocolloid or conventional dressing and compression therapy at four study centers. The ulcers had been present for a mean of 47.8 in the control and 46.2 weeks in the treatment group and 42% of all patients had recurrent ulcers. Ulcers treated with hydrocolloid dressings reduced 71% and control treated wounds reduced 43% in area after 7.2 weeks of treatment. Thirty-four percent of all ulcers healed. Mean time to healing was 7 weeks for the hydrocolloid dressing group and 8 weeks for the control group. Most ulcers were less painful at final evaluation, but reduction in pain was more pronounced in hydrocolloid-dressed ulcers (p = 0.03). At baseline as well as during follow-up, significant differences between study centers were observed. Ulcers in patients in the United Kingdom were larger and less likely to heal (p = 0.001). Size of the ulcer at baseline was associated with treatment response and time to healing (p = 0.002). Percent reduction in ulcer area after 2 weeks was also correlated with treatment outcome (p = 0.004) and time to healing (p = 0.002). When all treatment outcome predictors were analyzed together, only percent reduction in area after 2 weeks remained statistically significant (p = 0.002), with percent reduction during the first 2 weeks of treatment > 30% predicting healing. A hydropolymer dressing (Tielle) and a hydrocolloid dressing (Granuflex) were compared in a randomised controlled clinical study involving 100 patients with leg ulcers and 99 patients with pressure sores in the community. Statistically significant differences in favour of the hydropolymer dressing were detected for dressing leakage and odour production, but no statistically significant differences were recorded in the number of patients with either leg ulcers or pressure sores who healed in each treatment group. Cultured epidermal allografts have been successfully used to treat a variety of wounds. Their postulated mechanism of action is through release of cytokines that stimulate epithelialization. On the basis of previous experience we expected ulcers treated with cryopreserved cultured allografts (CCAs) to be healed by 6 weeks. Hydrocolloid dressings (HCDs) have also been reported to be effective in the treatment of venous ulcers.
                Our purpose was to compare the effectiveness of CCAs with HCDs in healing chronic venous ulcers.
                Forty-three patients with 47 ulcers were enrolled in a randomized controlled trial. Ulcers not healed by 6 weeks were changed to the other treatment.
                No difference in the number of healed ulcers between the two groups was observed at 6 weeks. Healing rate, percent reduction of initial ulcer size, and radial progression toward wound closure were significantly greater for CCAs than for HCDs. Pain relief was not significantly different.
                CCAs achieve more rapid healing and greater reduction in ulcer size than HCDs. To evaluate the safety and performance of Alione Hydrocapillary dressing (Coloplast A/S) in the management of highly exuding chronic venous leg ulcers and compare it with two hydropolymer dressings,Tielle and Tielle Plus (Johnson & Johnson).
                A comparative clinical trial was conducted on 97 patients with an ankle brachial pressure index > or = 0.8 and a highly exuding leg ulcer. Ulcer duration was at least four weeks. Treatment continued until healing or for a maximum of 12 months.
                There was no statistically significant difference in healing time or wound area reduction between the two treatment protocols. The test dressing (Alione Hydrocapillary) had better absorption capacity and was more comfortable for the patients than the comparator dressings (Tielle/Tielle Plus) and adhered less to the wound bed.Also, more patients preferred the test dressing to their previous treatment. Although severe leakage and maceration were observed more frequently in the comparator group compared with the test group, this was not statistically significant.
                Both treatment protocols were safe and effective in treating highly exuding chronic venous leg ulcers. The test dressing performed as well as or better than the comparator dressings for all study parameters and more patients preferred the test dressing to their previous dressing compared with the comparator dressings. A prospective, randomized study was conducted to compare the performance of 2 hydrocolloid dressings, hydrocolloid A and hydrocolloid B, in the treatment of venous insufficiency ulcers. A total of 31 patients were enrolled at 2 clinical sites. Complete wound closure (100% epithelialization) was observed in 59% of the patients treated with hydrocolloid A, compared with complete wound closure in 15% of the patients in the hydrocolloid B group (P <or=.03). Investigators also rated hydrocolloid A significantly better in ease of application, adhesion, conformability, exudate absorption, barrier properties, transparency, and patient comfort (P <or=.02). Significantly fewer patients in the hydrocolloid A group required unscheduled, product-related dressing changes (P <or=.02). In this clinical study, hydrocolloid A demonstrated excellent performance characteristics and was highly effective in treating venous insufficiency ulcers. In a multicentre, prospective, randomised trial of 44 patients with exuding leg ulcers, a new hydrofibre dressing was compared with an alginate dressing in terms of dressing performance, patient comfort, safety and cost-effectiveness. The groups were well matched with regard to sex and age. A statistically significant difference between treatment groups was observed in mean wear time, with a longer wear time of four days observed in the hydrofibre dressing group compared to three days in the alginate group. The hydrofibre dressing group therefore demonstrated a significantly lower frequency of dressing changes required per week. Significantly more patients achieved a seven-day wear time with the hydrofibre dressing than with the alginate dressing. There was no difference with regard to percentage change in ulcer area. Cost-effectiveness was based on the cost of dressings, compression therapy and nursing time to achieve a healed wound. However, because of small patient numbers, it was difficult to make an accurate comparison. This study suggests that the hydrofibre dressing may have clinical benefits that merit further investigation with larger patient numbers. Diabetic foot ulcers (DFUs) are at risk of infection and impaired healing, placing patients at risk of lower extremity amputation. DFU care requires debridement and dressings. A prospective, multicentre study compared clinical efficacy and safety of AQUACEL Hydrofiber dressings containing ionic silver (AQAg) with those of Algosteril calcium alginate (CA) dressings in managing out-patients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 DFUs.
                Patients stratified by antibiotic use on enrolment were randomly assigned to similar protocols including off-loading, AQAg (n = 67) or CA (n = 67) primary dressings and secondary foam dressings for 8 weeks or until healing. Clinical efficacy measures were healing outcomes and primarily healing speed. Adverse events were recorded.
                AQAg and CA groups were comparable at baseline. All ulcer healing outcomes improved in both groups. The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers (P = 0.34). AQAg-treated ulcers reduced in depth nearly twice as much as CA-treated ulcers (0.25 cm vs. 0.13 cm; P = 0.04). There was more overall ulcer improvement and less deterioration in AQAg subjects (P = 0.058), particularly in the subset initially using antibiotics (P = 0.02). Safety profiles of both groups were similar.
                When added to standard care with appropriate off-loading, AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings, specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment. This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing. To compare occlusive hydrocolloid dressing (OHD; Karayahesive) and gauze dressing (GD) with regard to the cost and incidence of wound infection after abdominal surgery.
                A total of 134 patients who underwent incisions were randomized to have their wounds dressed with either OHD or GD. OHD was left on until the sutures were removed, and GD was changed everyday postoperatively. The cost calculations represent the number of dressings required for each treatment group as determined by the frequency of required dressing changes and cost per dressing.
                There were no differences between the groups regarding the need for dressings to be changed or the incidence of infection. OHD was less expensive and complicated than GD, which needed to be changed everyday (p < 0.0001).
                The results suggest that OHD is less expensive to use than GD, and the risk of wound infection is not increased compared to GD. To assess the effect of different dressings on venous ulcer healing.
                A randomised clinical trial.
                Patients were randomised to treatment with one of three dressings: a zinc oxide impregnated bandage, a zinc oxide impregnated stockingette, or an alginate dressing. All patients were treated as outpatients and had compression bandaging with two minimal stretch bandages (Elastocrepe) and a stockingette (Tubigrip) to keep the bandages in place.
                One hundred and thirteen patients (133 ulcerated limbs) with chronic ulceration of the leg due to venous disease alone, and attending Fremantle Hospital Leg Ulcer Clinic, Western Australia were entered into the study. Healing was measured as complete healing of the ulcerated limb or failure of the limb to heal within 9 months.
                There was no significant difference between the three groups in ulcer size, duration, and other parameters compared. Healing was affected significantly by ulcer size and which leg was ulcerated. There was significantly faster healing with the paste bandage.
                The use of a paste bandage significantly improved the healing of chronic venous ulcers when used in combination with compression bandaging, and compared to an alginate dressing and a zinc oxide impregnated stockingette. To compare the effect on the microcirculation in venous leg ulcers (VLUs) of two treatment regimens that promote a moist wound environment versus paraffin gauze. The hypothesis is that moist wound dressings are more likely to stimulate the microcirculation and therefore angiogenesis.
                Patients with non-healing VLUs were randomised to receive either a foam dressing (Suprasorb P), a collagen dressing (Suprasorb C) plus the foam dressing, or paraffin gauze (control). All patients wore short-stretch high compression bandages. Parameters used to measure the effects of the treatments on the microcirculation were: TcPO2 measurements, video laser Doppler measurements and the number of capillaries in the wound bed. The progression towards healing was measured by the reduction in ulcer area and formation of granulation tissue. The treatment period was four weeks.
                Significant increases in TcPO2 values were reported between baseline and week 4 for patients receiving the foam dressing only or the collagen plus foam dressing combination (p<0.008 versus p<0.003 respectively). There was also a significant increase in the number of capillaries for the collagen plus foam treatment only (p<0.002).
                This pilot study suggests that a moist wound environment stimulates perfusion of blood and oxygen to the wound tissue, thereby promoting angiogenesis. The collagen and foam dressing combination demonstrated superior results to the control and the foam dressing only. Monitoring the microcirculation may help to assess the effect of dressings on VLU healing, although more research is needed.
                This pilot study was supported by a limited grant from Lohmann & Rauscher GmbH, Germany. A multicenter prospective randomized clinical trial was undertaken to compare two foam dressings (Allevyn Hydrocellular, Smith & Nephew and Mepilex, Molnlycke Health Care AB) in the management of chronic venous leg ulceration. Patients were also randomized to two compression bandage systems (4-layer vs. cohesive short stretch) as a factorial design. Those with causes of ulceration other than venous disease were excluded. In all, 156 patients met the entry criteria and were randomized from the 12 clinical centers with a median (range) ulcer size of 4.33 (0.33-123.10) cm(2). After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died. Of the patients randomized to Mepilex, 50/75 (66.7%) had complete ulcer healing compared with 50/81 (61.7%) on Allevyn. The hazard ratio for healing after adjustment for bandage type and trial center was 1.48 (95% C.I. 0.87-2.54, p=0.15), which only marginally changed following adjustment for baseline variables, neither of which achieved statistical significance (p=0.16). Withdrawal rates were similar between groups (23, 30.7% Mepilex vs. 23, 28.4% Allevyn). Pain improved following treatment with both dressings (p<0.001), but with no difference between dressings.
The type of dressing applied beneath compression has not been shown to affect ulcer healing. For the majority of dressing types there was insufficient data to allow us to draw strong conclusions except for hydrocolloid compared with a low adherent dressing. The result of the meta-analysis indicate no significant difference in healing rates between hydrocolloid dressings and simple, low-adherent dressings when used beneath compression. Decisions regarding which dressing to apply should be based on local costs of dressings and practitioner or patient preferences.