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As part of its Medical Technology Evaluation Programme, the National Institute for Health and Care Excellence (NICE) invited a manufacturer to provide clinical and economic evidence for the evaluation of the Debrisoft(®) monofilament debridement pad for use in acute or chronic wounds. The University of Birmingham and Brunel University, acting as a consortium, was commissioned to act as an External Assessment Centre (EAC) for NICE, independently appraising the submission. This article is an overview of the original evidence submitted, the EAC's findings and the final NICE guidance issued. The sponsor submitted a simple cost analysis to estimate the costs of using Debrisoft(®) to debride wounds compared with saline and gauze, hydrogel and larvae. Separate analyses were conducted for applications in home and applications in a clinic setting. The analysis took an UK National Health Service (NHS) perspective. It incorporated the costs of the technologies and supplementary technologies (such as dressings) and the costs of their application by a district nurse. The sponsor concluded that Debrisoft(®) was cost saving relative to the comparators. The EAC made amendments to the sponsor analysis to correct for errors and to reflect alternative assumptions. Debrisoft(®) remained cost saving in most analyses and savings ranged from £77 to £222 per patient compared with hydrogel, from £97 to £347 compared with saline and gauze, and from £180 to £484 compared with larvae depending on the assumptions included in the analysis and whether debridement took place in a home or clinic setting. All analyses were severely limited by the available data on effectiveness, in particular a lack of comparative studies and that the effectiveness data for the comparators came from studies reporting different clinical endpoints compared with Debrisoft(®). The Medical Technologies Advisory Committee made a positive recommendation for adoption of Debrisoft(®) and this has been published as a NICE medical technology guidance (MTG17).

OBJECTIVE

Late-stage lymphoedema is characterised by chronic swelling, shape distortion, inflammatory processes and tissue fibrosis. Our aim was to perform a clinical audit of a lymphoedema compression bandaging system (Rosidal Soft foam roll layer and figure-of-eight application of Actico cohesive inelastic bandages) specifically designed for patients with late stage lower limb lymphoedema.

METHOD

The audit explored suitability of the bandaging system, benchmarking limb volume changes with research evidence, and reporting patient and practitioner evaluations.

RESULTS

A mean reduction (33%) in excess limb volume was reported for the 11 patients with unilateral lymphoedema who completed a course of bandaging over 12 days. Mean percentage reduction of absolute limb volume after treatment was 8%. Patient and practitioner evaluations indicated the suitability of this bandage system for patients with late stage lymphoedema in terms of comfort and effectiveness.

CONCLUSION

The bandaging system is suitable for patients with late stage chronic swelling. Two parameters for calculating change in limb volume are not interchangeable. Future evaluation of the bandaging system, using validated outcome measures within a comprehensive research study is required.

DECLARATION OF INTEREST

Activa Healthcare provided financial support to the project and supplied the materials.

BACKGROUND

Wound infection plays an important role in compromised wound healing. A high bioburden impairs healing and leads to formation of a chronic wound. Distinctly higher pH values were observed in chronic wounds compared to acute wounds. However, there is only limited knowledge of pH dependency on the antibacterial efficacy of common antimicrobial substances.

METHODS

This study investigated the pH influence on the antimicrobial efficacy of povidone (PVP)-iodine, silver nitrate, chlorhexidine, octenidine and polihexanide against Staphylococcus aureus and Pseudomonas aeruginosa using the agar diffusion test and microplate laser nephelometry.

RESULTS

The bactericidal activity of chlorhexidine and octenidine was mainly pH-independent in a pH range of 5.0-9.0. In contrast, polihexanide showed a significant efficacy increase at a higher pH. It was also found that the influence of the pH on antiseptics differs among species of bacteria. For instance, S. aureus exhibited an increasing sensitivity against silver nitrate with rising pH whereas the effect on P. aeruginosa was found to be distinctly decreased. The antimicrobial effect of PVP-iodine was strongly diminished with rising pH.

CONCLUSIONS

The shift towards higher pH values in chronic wounds compared to acute wounds makes it imperative to know whether the antimicrobial efficacy of applied antimicrobial substances is altered by different pH levels. The results suggest that application of polihexanide might be advantageous for the management of wound infections, as both S. aureus and P. aeruginosa exhibited an increased susceptibility with rising pH.

During surgical procedures, abdominal swabs are routinely used to adsorb blood from the operation field and for the retention of tissues and organs. Due to the material characteristics, abdominal swabs exhibit a slight procoagulant activity, which is usually desirable and mostly harmless. However, during cardiac surgery with heart-lung machine (HLM) support, abnormal clot formation may result in life-threatening thromboembolic complications. Therefore, a simple clotting test (SCT) allowing in vitro detection of abdominal swabs with elevated hypercoagulant potency in the presence of heparinized human blood was developed and validated. In order to establish a SCT, heparinized human blood from 100 donors was incubated with five different cotton abdominal swabs for 30 min at 37 °C and then macroscopically analyzed. In a second study, 10 other swabs were screened with the established SCT (n=11) to confirm its suitability. Scanning electron microscopy, measurements of activated clotting times and thrombin-antithrombin were further performed. In the SCT, the results are dichotomized as negative (no detectable blood clot) and positive (blood clot formation). In the first study, three of the five tested abdominal swabs exhibited hypercoagulant potency in at least 25% of the donors. Calculations using the binomial distribution showed that blood of 11 donors is needed for routine testing with the SCT, which was confirmed in the second study using another 10 swabs. The established SCT can be used for detection of abdominal swabs with an elevated procoagulant potency, thereby minimizing the risk of thromboembolic complications during cardiac surgery with HLM support.

Die Prävalenz venöser Abflussstörungen als Ursache einer chronischen Wundheilungsstörung wird je nach Veröffentlichung mit bis zu 80% aller chronischen Ulzerationen am Unterschenkel angegeben. Somit ist die venöse Abflussstörung die häufigste Ursache von Ulcera cruris.

BACKGROUND

The simultaneous use of abdominal and endoscopic vacuum therapy in a case of an abdominal abscess caused by gastric perforation is demonstrated and innovative operative endoscopic management is described.

CASE REPORT

A computed tomography scan performed on a 67-year-old female patient showed a large abscess of the upper abdominal cavity where laparoscopic fundoplication had been performed 6 months previously. Endoscopy showed a transmural perforation of the dorsal wall of the stomach. The gastric perforation was closed and drained using intracavitary endoscopic vacuum therapy. Open pore polyurethane foam drainage was inserted through the defect into the extraluminal cavity for 3 days. A second period of therapy followed using intraluminal therapy with total drainage of the stomach, simultaneous enteral nutrition via a jejunal tube and a vacuum pressure of - 125 mmHg was applied with an electronic vacuum device. The abdominal abscess was drained via laparotomy and intra-abdominal vacuum therapy was performed with an open pore double-layered film using a vacuum pressure of - 75 mmHg. The perforation defect was not treated by operative means. Abdominal vacuum therapy ended 3 days postoperatively and the abdominal wall was closed by suture. Endoscopic vacuum therapy of the gastric perforation was terminated after 7 days and primary wound healing could then be achieved.

CONCLUSION

Use of endoscopic and abdominal vacuum therapy as well as new open pore material is an innovative option for operative management.

BACKGROUND AND STUDY AIMS

Endoscopic Vacuum Therapy (EVT) has been reported as a novel treatment option for esophageal leakage. We present our results in the treatment of iatrogenic perforation with EVT in a case series of 10 patients.

PATIENTS AND METHODS

An open pore polyurethane drainage was placed either intracavitary through the perforation defect or intraluminal covering the defect zone. Application of vacuum suction with an electronic device (continuous negative pressure, -125 mmHg) resulted in defect closure and internal drainage.

RESULTS

Esophageal perforations were located from the cricopharyngeus (4/10) to the esophagogastric junction (2/10). EVT was feasible in all patients. Eight patients were treated with intraluminal EVT, one with intracavitary EVT, and one with both types of treatments. All perforations (100 %) were healed in within a median of (3 - 7) days. No stenosis occurred, no complications were observed, and no additional operative treatment was necessary.

CONCLUSIONS

Our study suggests that intraluminal EVT will play an important role in endoscopic management of esophageal perforation.