Clinical Newsletter
Regular updates on our latest clinical studies.
Onze teams van Onderzoek en Ontwikkeling zijn wereldwijd werkzaam, en creëren synergieën met onze deskundigheid en verwante vakdisciplines. Wij wisselen internationaal veel van gedachten met onafhankelijke, gespecialiseerde instituten, belangrijke opinieleiders en kennisverspreiders om zo samenwerkings- en kennismanagement op het hoogste niveau te kunnen garanderen. In het kader daarvan voeren wij grote studies uit die voortdurend op congressen in de vorm van posters of lezingen van onze partners, op symposia en in workshops worden gepresenteerd, en ook in befaamde wetenschappelijke tijdschriften worden gepubliceerd. De voor het grootste deel door onafhankelijke deskundigen beoordeelde, op bewijs gebaseerde vakpublicaties stellen wij u graag in deze databank ter beschikking:
Background and study aims
Endoscopic negative pressure therapy (ENPT) has been developed to treat gastrointestinal leakages. Up to now, ENPT has usually been performed with open-pore polyurethane foam drains (OPD). A big disadvantage of the OPDs is their large diameter. We have developed a new, small-bore open-pore film drainage (OFD). Herein we report our first experience in a case series of 16 patients.
Patients and methods
OFD is constructed with a drainage tube and a very thin double-layered open-pore drainage film (Suprasorb CNP, Drainage Film, Lohmann & Rauscher International, Germany). The distal end of the tube is wrapped with only one layer of film. OFD is placed into the gastrointestinal leakage site with common endoscopic techniques. The tube is connected to an electronic vacuum device and continuous negative pressure of -125 mmHg applied.
Results
From 2013 to 2016, 16 patients were treated with the new OFD device. In 10 patients, transmural intestinal defects (4 esophageal, 4 rectum/colon, 1 duodenal, 1 pancreatic cyst) were closed with ENPT in median time of 12 days (range 3 - 34 days). Five of the 10 patients were treated solely with OFD devices. In five patients ENPT started with ODP and changed to OFD when the cavity was shrunken to a channel with a small opening. In four patients postoperative gastric reflux was eliminated for 5 to 16 days.
Conclusions
Small-bore OFD opens up promising new treatment options within ENPT. OFD can be used in endoscopic closure management of intestinal leakages in the upper and lower gastrointestinal tract. Gastric reflux can be eliminated in an active manner. OFD can be inserted nasally. OFD may be an adequate substitute for OPD, especially when placement of the larger OPD is difficult.
OBJECTIVE
The time taken to reach maximal haemostatic effect following local anaesthesia with epinephrine is generally believed to be <10 min. This is based on clinical experience and indirect measurements of perfusion using methods such as laser Doppler flowmetry and oxygen spectroscopy. However, the only study in which bleeding has been measured quantitatively in an intra-operative setting in humans showed that the full haemostatic effect was not achieved until 30 min after anaesthesia. The aim of this study was to determine the time taken to reach maximum haemostatic effect when using epinephrine for local anaesthesia in oculoplastic surgery.
METHODS
Intra-operative bleeding following infiltration anaesthesia with either lidocaine 20 mg/ml (2%) or lidocaine + epinephrine 12.5 μg/ml (1:80 000) was measured after 7, 15 and 30 min in the eyelids of 16 patients undergoing upper eyelid blepharoplasty.
RESULTS
Bleeding was decreased by 74.6% (with 95% CI, 6.16-87.6%) 7 min after the injection of lidocaine + epinephrine (p = 0.0048) compared with lidocaine without epinephrine. There was no further decrease in bleeding after 15 or 30 min (p = n.s.).
CONCLUSION
The optimal time for skin incision in eyelid surgery is within 7 min of injection of lidocaine with epinephrine. Waiting longer does not lead to a further decrease in bleeding.
A male patient aged 64 years with learning difficulties who lives alone presented to his GP with increasingly swollen legs. The patient attended a day centre five days per week and enjoyed many of the activities on offer there. His legs were itchy and painful and over time as the swelling increased, his mobility gradually declined. Due to fear of being admitted to hospital and the worry of possible amputation, the patient did not disclose the degree of pain he was in to his GP. The patient later disclosed to nurses that when he was in shops that people would comment on the smell from his legs, he was refused service in cafes and people moved away when on buses. His condition was having a huge impact on his life and his demeanour. He was prescribed cream by his GP to apply to his legs and when necessary antibiotics were prescribed. Following 6 years of increased swelling, recurrent cellulitis and pain, he was persuaded to visit his GP with his keyworker in attendance.
Introduction
The delivery of effective wound management in a total care setting, including prevention, hospitals, home care and emergency facilities, may fail due to a lack of standardized procedures and optimal communication.1,2 A project was developed in the Azienda USL, south east Toscana, Italy, a region of about 300 x 150 km with a population of 850.000. Daily, on average 1200 community patients receive wound management. The aim of the project was to build an integrated network of services, facilitating synergies between structures, improving patient quality of care.
Method
A multidisciplinary team approach was used sharing good clinical wound management practices and organizational assistance to overcome compartmentalized individual services. A clinical pathway for wound management was developed and implemented to improve patient quality of care making optimal use of available resources. The individualized clinical pathway addressed the path a patient with a complex wound follows within the health care system, taking into account clinical governance, patient’s wellbeing and quality control assurance as well as limited resources. After implementation of the pathway success was measured looking at process indicators and outcome as well as patients satisfaction and improvement of care, such as the implementation of new technology or insights. The pathway included patient entry/on-site debridement/cleansing, wound re-evaluation, and individual wound bed preparation.
Currently in the community enzymatic and autolytic debridement is used for patients with wounds that contain sloughy tissue. To address the need for mechanical debridement a monofilament debrider was evaluated for its added value in terms of efficacy, safety, tolerability and ease of use, compared to current methods.3 The 15 day study included 80 community patients with complex wounds of various etiologies containing sloughy tissue. After giving consent the patients were allocated at random to 3 different treatment groups. During follow up visits a questionnaire, using a 5-point Likert scale, was completed scoring wound condition, patient reported comfort/pain during debridement, time required for the procedure and product handling. Costs were calculated taking into account clinical efficacy, time to debridement, number of home visits, nursing costs, costs per product used.
Results
After implementation of the pathway communication between the various disciplines had improved as well as treatment outcomes. Fewer visits were required as more appropriate technologies were used and interventions were performed at an earlier stage, possibly preventing complications. Different departments within the network of services can keep tracing the patients’ condition in the same pre-existing unit of the healthcare system.
Regarding debridement, the 2 types of monofilament products were demonstrated to be effective and safe and delivered faster debridement compared to the enzymatic and autolytic products. Cost was significantly lower in the monofilament group (Euro 58,67 and Euro 72,47 versus enzymatic Euro 213,35 and autolytic debridement Euro 98,67) due to a reduction in debridement time, number of visits and nursing time.
Discussion
In addition to improving the quality of wound care, the establishment of a multidisciplinary team approach, sharing good clinical wound management practices and organizational assistance will not only improve patients’ pain and activities of daily life, but also achieve improved overall health, an approach believed to have positive effects on reducing costs and relieving the burden on the healthcare system.1,2 A clinical pathway for wound management can be a valuable tool to improve patient quality of care making optimal use of available resources.1,2 Debridement is an important part of wound management. In clinical studies mechanical wound cleansing and debridement using a monofilament polyester fiber product was effective, pain and trauma free.3 The monofilament products implemented as part of the debridement portfolio were shown to deliver better and faster debridement than the previously used products and were well tolerated by the patients.
Conclusion
The organisational change allowed for staff to approach patients in person, administer adequate wound assessment, and to perform on-time debridement. Both the number of visits and nursing time was reduced leading to a significant reduction in total cost of debridement.
Introduction
Non-healing, complex or stalled wounds fail to heal in the expected time required for tissue repair, in spite of their optimal wound management.1,2 Wound management requires addressing the etiologic causes and underlying disorders such as venous hypertension.2 A multidisciplinary approach to wound management including the whole chain of care is recommended. A project was developed in the Azienda USL, south east Toscana, Italy, a region of about 300 x 150 km, to improve quality of care for patients with wounds. The region has 8 hospitals and 13 nursing homes for a population of 850.000. Daily, on average 1200 community patients receive wound management. The project aimed to improve knowlegde and skills when delivering wound treatment in the community. The current study compared clinical efficacy and cost of autolitic, enzymatic and mechanical debridement using a monofillament pad and a pad with a hanle.
Method
Currently in the community enzymatic and autolytic debridement is used for patients with wounds that contain sloughy tissue. To address the need for mechanical debridement a monofilament debrider was proposed for its added value in terms of efficacy, safety, tolerability, results and ease of use.3-6 Eighty community patients with complex wounds of various etiologies containing sloughy tissue were included in the study and followed up for 15 days. Patients gave informed consent. Patients were allocated to the different treatment groups at random. At baseline patient's medical history, wound characteristics and privious treatment was recorded. During follow up visits a questionnaire was completed scoring wound condition, patient reported comfort/pain during debridement, time required for the procedure and product handling, using a 5-point Likert scale. Costs were calculated taking into account clinical efficacy, time to debridement, number of home visits, nursing costs, costs per product used.
Results
Debridement was effective and comfortable using all evaluated methods (on a 5-point Likert scale, the 2 types of monofilament products scored a mean of 4,9 and 4,8, enzymatic debridement sored a mean of 4,6 and autolytic debridement a mean of 3,6). The total costs for debridement using the monofilament pad and product with handle was Euro 58,67 and Euro 72,47 respectively. For enzymatic debridement the total costs were Euro 213,35 and for autolytic debridement total costs were Euro 98,67. Cost was significantly lower in the monofilament group due to a reduction in debridement time, number of visits and nursing time. Based on these results the monofilament product is proposed to be added to the list of products available for wound debridement in the community.
Discussion
Mechanical debridement is historically associated with the use of wet-to-dry gauze, which non-discriminatorily removes devitalized tissue, resulting in significant pain and damage to healthy tissue.1,2 Enzymatic and autolytic debridement may be slow and not suitable for wounds such as diabetic foot ulcers. In clinical studies mechanical wound cleansing and debridement using a monofilament polyester fiber product was effective, pain and trauma free.3-6 Our study showed the monofilament products to deliver better and faster debridement and a good patient tolerance. Both the number of visits and nursing time was reduced leading to a significant reduction in total cost of debridement.
Conclusion
The addition of the monofilament products to our debridement portfolio use for wound management in the community represents an essential added value in the range of dressings available for patients with complex wounds with appropriate use of tight resources.