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This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB.

Die Kompressionstherapie bleibt eine entscheidende Säule der Phlebologie. Der therapeutische Zentralsatz lautet: Heilphase mit nicht nachgiebigen Verbänden -Erhaltungsphase mit elastischem Material (Kompressionsstrumpf). Indikationen, Anlagetechnik und das Verbandmaterial für den ein-fachsten der »Fischer-Verbände«, den Druckverband, wird aufgezeigt. Dieser kann vom Patienten nach Anleitung selbst gewickelt werden.

Die ambulante Therapie der tiefen Beinvenenthrombose erlebt eine Renaissance. Durchgeführt wird sie mit Kompressionsverbänden nach Heinrich Fischer. DieTechnik und das Material für den nicht nachgiebigen und den nachgiebigen fixierten Unterschenkel-Kompressionsverband werden vorgestellt.

Aim:

To evaluate the safety and performance of an aluminized, low-adherent wound dressing for the treatment of acute wounds in routine clinical practice.

Method:

A prospective, multicentre, observational Post-Market Clinical Follow-up (PMCF) study was conducted involving 63 healthcare professionals, nurses with a specialisation in wound management, who treated 434 patients, primarily with acute wounds, over several weeks according to standard clinical practice in Germany, Austria, Belgium, and Colombia. After treatment with the aluminized, low-adherent1 wound dressing, participants completed a questionnaire, either online or paper based, assessing key parameters such as performance, quality, usability, and safety.

Results/Discussion:

Several wounds were treated, predominantly acute (82.5%) with low to moderate exudate levels, including burns, post-operative wounds, skin tears, cuts, and abrasions. Most participants applied the dressing for up to 7 days on a single patient, with dressing changes typically occurring every 2–3 days. The dressing provided consistent and reliable wound coverage, effectively managed exudate, and minimized the risk of adhesion, enabling atraumatic dressing changes. The majority of participants (85.7%) reported that the atraumatic dressing changes and the established wound rest provided by the dressing positively influenced the healing process, confirming its supportive role in wound healing. Clinicians described the dressing as soft, smooth, and gentle on the wound. Overall ratings on a six-point scale were favorable: performance (mean 2.25), safety (mean 2.21), and usability (mean 2.26). While nine side effects were reported, no severe adverse events occurred.

Conclusion:

Study results confirmed that the aluminized, low-adherent1 wound dressing is safe, well tolerated, and effective for treating acute wounds in routine clinical practice. It reduces the risk of wound adhesion and pain during dressing changes, thereby supporting wound healing.

Introduction

This study was commenced to evaluate practical aspects of usage of PHMB-impregnated bacterial cellulose dressing* (primarily, a choice of adequate secondary dressing), its safety and performance. The primary endpoint was ability of primary/secondary dressing combination to maintain moist wound environment under the conditions of routine use. Secondary endpoints were different aspects of wound and patient’s general condition.

Method

Patients with chronic (venous leg ulcer, diabetic foot ulcer) and acute (post-operative) infected wounds or wounds at risk of infection received study dressing for 14±3 days in combination with a secondary dressing, chosen according to the exudation grade. Possible types of the secondary dressing were: film**, foam***, surgical dressing**** or just a plaster***** for fixation, each type was used by at least 4 patients within each indication.

Results

56 subjects were enrolled in the study and 53 included in the PP (per protocol population): venous leg ulcer=18, diabetic foot ulcer=18 and post-operative wound=17.

Condition of the study dressing after removal of a secondary dressing was described as moist or only partially dried-out for 89.0% of dressing changes, and in the specific groups it composed 100.0% (film), 91.7% (surgical dressing), 88.4% (foam) and 75% (plaster). Users assessed easiness of dressing removal as “very easy” (80.0%) or “easy” (20.0%) and dressing dislocation rate was 2.0% (3 cases out of 150 dressing changes). Complete healing was observed for all patients (N=17) in the post-operative wound group, and the overall relative change of the wound area was -72.2 [-100.0,-18.7]%, p<0.001. Condition of the wound surrounding skin improved (intact 32.1% at baseline vs. 71.7% at the final visit, p<0.001), without statistically significant difference between groups. For non-healed wounds, relative areas of necrosis (mean (SD)=-4.7 (14.4), p=0.022) and fibrin (-13.9 (39.9), p=0.019) decreased, and the area of granulation increased (mean (SD)=18.6 (42.3), p=0.011). Decrease of odour (18.9% vs. 2.0%, p=0.018), pain (median 3.0 [IQR 0.0 - 5.0] vs. 0.0 [IQR 0.0 - 1.0], p<0.001), exudation (none: 1.9% vs. 35.8%, slight: 62.3% vs 56.6%, moderate: 35.8% vs. 7.5%, p<0.001) was observed. Rate of non-infected wounds

increased between baseline and final visit (59.6% vs. 94.3%), rate of critically colonized (21.2% vs. 5.7%) and infected wounds (19.2% vs. 0.0%) decreased (p<0.001). Quality of life increased (mean 6.5±1.9 at baseline vs 7.4±1.6 at the final visit, p<0.001). Mean frequency of dressing changes was 1.46±0.54 per week. Overall investigator assessment of the dressing was “very good” or “good” in 86.8% of cases. One safety event (allergy) was registered and assessed as possibly related to the study product.

Discussion

The choice of secondary dressing affected ability of study dressing to maintain moist wound conditions, with film and island dressings recommended for optimal moisture balance and foam dressing recommended for the wounds with initially high exudation level only. Usage of the dressing with only a fixation is not recommended (risk of drying-out).

Conclusion

Study dressing demonstrated good antimicrobial and healing properties in all study indications and an acceptable safety profile.

Introduction:

The treatment of infected chronic wounds is a challenge in everyday clinical practice. In the treatment of these wounds polyhexanide (PHMB) is the antiseptic of choice [1]. Patients with difficult personal backgrounds further complicate the successful treatment of these wounds. Two case studies of infected chronic lower leg ulcers are presented. The treatment was carried out with an antimicrobial wound dressing made of cellulose containing PHMB*.

Method:

Patient 1: A 27-year-old male patient from the UK with an infected venous leg ulcer on the right lower leg that had been present for 11 months (size: 315 cm², depth: 0.1 cm). Moderate exudation, odour and pain of VAS=7 present. A deep vein thrombosis has recently occurred. In addition, the patient suffers from drug addiction (intravenous), alcohol addiction and mental disorder. The patient was previously treated with a hydrogel-impregnated antimicrobial wound pad and a medical-grade honey dressing. The new treatment consisted of cleaning with a monofilament fibre debridement pad**, the antimicrobial cellulose dressing, a sterile absorbent compress and a tubular dressing as a secondary dressing.

Patient 2: An 80-year-old male patient from Germany with a mixed gaiter ulcer on the right lower leg (size: 450 cm², depth: 1 cm). Before the patient was admitted for treatment, he had already had several inpatient hospital stays. Therapy with a split-thickness skin graft was unsuccessful. The wound is infected with multidrug resistant gram-negative bacteria (MDRGN bacteria). The patient has had several antibiosis. The patient showed a constant incompliance with regard to the therapy attempts. Finally, a healing attempt with medicinal clay took place on the advice of his alternative (non-medical) practitioner. The patient was taken over with a massive infection, severe exudation and odour formation. Wound and lower leg pain correspondent to 8 on the Visual Analogue Scale (VAS). The entire lower leg was oedematous and papular indurations were present in the area of the forefoot. The wound was covered with biofilm and partially with fibrin. The wound edges and the surrounding skin were inflamed. Individual lesions were present. The patient's hygiene was poor. The weekly treatment was as follows: The wound was first cleaned with a wound irrigation solution containing sodium hypochlorite and a monofilament fibre debridement pad. The primary wound dressing was the cellulose dressing with PHMB. A highly absorbent wound compress*** and a superabsorbent wound dressing‡ served as a secondary dressing. In addition, the edema was treated with a compression bandage‡‡.

Results:

Patient 1: After 14 days and 5 dressing changes, the wound pain had decreased significantly (VAS = 1). The wound odour was gone. While the beginning granulation of the previously stagnant wound was particularly positive from the point of view of the user, the patient was particularly pleased that the wound odour had disappeared and that wound exudate no longer penetrated the dressing. The treatment was continued accordingly.

Patient 2: After 3 weeks, not only had the wound pain (VAS = 6-7) decreased, but the wound odour and signs of infection had disappeared. Granulation tissue was visible. After 4 weeks, the wound pain (VAS = 5-6) decreased even more. Although the patient acknowledged the success of the therapy and the reduction in pain, he stopped the treatment on the advice of his alternative practitioner.

Discussion:

Although the two cases involved patients with longstanding chronic wounds and difficult personal backgrounds, the users were able to heal the wound within a short time with the help of the antimicrobial cellulose wound dressing and adequate modern wound care. For the two users, the rapid treatment success, in the form of the beginning healing, was gratifying. For the patients, it was primarily the pain reduction and the decrease in wound odour that were particularly well received. This is not surprising, as these two factors play a major role in the patient's quality of life.

Conclusion:

The antimicrobial wound dressing proved to be a suitable for the treatment of infected chronic wounds.

Aim:

Compression remains the gold standard for long-term management of chronic edema. Reviews have shown that the benefits of compression diminish according to levels of non-adherence. Reasons commonly stated for nonadherence to compression include inconvenience, heat, cost, and pain. We hypothesize that offering compression options will have positive impact on patients’ compliance and concordance to compression regimens.

Method:

Observational study performed at 2 different edema management clinics. Ten patients presenting with lower extremity swelling and history of non-compliance with previous compression regiments were observed. Objective data measured included limb volume, range of motion (ROM), functional activity status using the Timed Up and Go(TUG), and assessment of quality of life (QOL) using the Lymphoedema QOL Tool (LYMQOL-LEG). Measurements were taken at four different intervals over a minimum of 3 months. Compression options were individualized to patient's physical presentation and lifestyle for long term management of their edema.

Results / Discussion:

Compression therapy had a positive impact on all outcomes measured during the intensive phase of therapy. Follow-up outside the intensive phase of therapy demonstrated further volume loss in 6/10 subjects; Volume remained constant 3/10, increased slightly 1/10. LYMQOL scores and functional performance level maintained stable during the follow-up period.

Conclusion:

Offering multiple compression options including custom and ready-to-wear flat knit stockings*, an adjustable wrap ** and nighttime compression options*** had a positive impact on patients’ adherence to compression regimens during the study period compared to single compression modalities offered previously. Individualizing the compression regimen to each patient’s lifestyle improved their adherence to chronic edema management.

Aim:

Chronic edema of the lower leg has a negative impact on functional performance. Chronic edema impairs foot wear use and normal gait patterns, impairs calf muscle pump and most importantly limits the patient’s ability to interact with his/her environment. This negative spiral of progressive edema and progressive decline in functional status can be

reversed simply by addressing the edema.

Method:

Observational study performed at 2 separate outpatient edema management clinics. Eight patients were referred for lower extremity edema management to a physical therapist. Objective data measured including limb volume, ankle range of motion (ROM), functional activity status utilizing the Timed Up and Go (TUG) and the 4 meter walk test (4MWT), and assessment of quality of life (QOL) via the Lymphoedema QOL tool (LYMQOLLeg). Measurements were taken at initial evaluation, upon completion of treatment, and 2 weeks post treatment. Patients received compression therapies* and instruction in home exercise program only. Gait training was performed during the sessions for safety with assistive device when appropriate.

Results / Discussion:

Reduction of swelling had a direct positive impact on all outcomes measured. LYMQOL-Leg scores and functional performance scores (TUG and 4MWT) improved by 15% and 0.1m/sec respectively. Functional performance continued to improve after active therapy had been discontinued with further increased TUG scores at the 2-week follow-up assessment. The reduced edema allowed for normal footwear use, normalized gait patterns which increased mobility and enhanced QOL.

Conclusion:

Management of lower extremity edema has a positive impact on both patient’s functional status and QOL.