PROFORE^◊

Flerlags-kompressionssystem

Om PROFORE

PROFORE er et flerlagskompressionssystem, som er udviklet til at give vedvarende, gradueret kompression ved behandling af venøse bensår eller lignende tilstande. Kompressionsbandager med flere lag er førstevalgsbehandlingen til venøse bensår.¹

PROFORE ier guldstandarden for kompressionssystemer med 4 lag, hvilket understøttes af ekstensiv klinisk evidens og support . Der findes en lang række produkter til forskellige patientbehov og der ydes ekspertsupport gennem uddannelsesdage og oplæring.

PROFORE giver ca. 40mm Hg tryk ved anklen, hvilket gradvist reduceres til 17mm Hg ved knæet.²

Hvad er et bensår?

Et bensår kan defineres som et sår under knæet, der ikke heler inden for 6 uger. Bensår kan ofte være grimme, smertefulde og langsomme til at hele. Uanset om de er venøse, arterielle eller af anden ætiologi, behandles næsten 80% af alle patienter med bensår i hjemmeplejen.^{3, 4}

Behandlingen af bensår kan reduceres til én gang om ugen ved brug af flerlagsbandager, da disse kan bæres i op til 7 dage.

PROFORE Produktsortiment

PROFORE Product Range

Forklaring
PROFORE Range Key

PROFORE komponenter

Alle komponenterne i PROFORE flerlagssystemet kan købes seperat.

PROFORE #1	PROFORE #2
PROFORE #3	PROFORE #4

Referencer

¹ Understanding Compression Therapy EWMA Position Document 2003

² Blair, SD, Wright, Dl, et al. Sustained compression and healing of chronic venous ulcers. BMJ (1998): 297: 1159-1161

³ Moffat C J, Oldroyd M I, Professional Nurse 1994; 9:486-497

⁴ Callum M J et al BMJ 1985; 290:1855-1856

⁵ The Charing Cross approach to venous ulcers Moffatt C, Stubbings N, Nursing Standard 1990; 5 12(10): 6-9

Klinisk dokumentation

PROFORE Multi-Layer Compression System: The First Choice Treatment for Venous Leg Ulcers

A meta-analysis of 5 clinical trials with 797 individual patient data highlights a definitive improvement in healing rates of venous leg ulcers with four-layer compression bandage (4LB) as opposed to short-stretch bandage (SSB). ¹

The median days to healing were 90 days with 4LB compared with 99 days with SSB. There is significant evidence that 4LB heals patients faster than SSB. Patients are 36% more likely to heal with 4LB compared to SSB during a period of treatment.

PROFORE has been shown to achieve complete wound closure in 79% of venous ulcers by 12 weeks and 84% by 24 weeks. ²

First Line Therapy for Venous Leg Ulcers: A Recommended Management Pathway

The International Leg Ulcer Advisory Board (ILUAB) is an international expert panel comprising of some of the most eminent clinicians and researchers in the field of venous leg ulceration. Following an extensive review of the literature available on venous leg ulcers the Leg Ulcer Advisory Board met to design a recommended management pathway for the condition.

Download pdf of the recommended management pathway (Size 595KB)

Top 12 Clinical Papers:

Author	O'Meara S, Tierney J, Cullum N, Bland M, Cooper P, Franks P, Mole T, Partsch H, Scriven M
Title	Four-layer compression bandage compared with short-stretch bandage for venous leg ulcers
Reference	In Press, currently BMJ 2009 presentation
Summary	Meta-analysis of 5 clinical trials with individual patient data, suggesting a definitive improvement in healing rates with 4LB as opposed to SSB. The median days to healing were 90 days with 4LB compared with 99 days with SSB. There is significant evidence that 4LB heals patients faster than SSB. Patients are 36% more likely to heal with 4LB compared to SSB during a period of treatment. This is the first meta-analysis using individual patient data in wound healing. Rigorously analysed and checked data covering 5 randomised clinical trials and 797 patients indicate that 4LB is more effective than SSB in the treatment of venous leg ulcers, with 4LB healing patients faster.

Author	Gannon R
Title	A review of the four layer vs the short stretch bandage system
Reference	Br J Nurs 16(11):S14-8 2007
Summary	A highly analytical and rigorous review of the studies in this area, assessing their strength and possible sources of bias. It concludes that 4LB is a better system than SSB. Studies that favour SSB have generally been carried out in centres that are not familiar with 4LB and therefore are not applying it properly.

Author	Cullum N, Nelson EA, Fletcher AW, Sheldon TA.
Title	Compression for venous leg ulcers
Reference	Cochrane Database Syst Rev (3): CD000265 2000
Summary	A very important review collecting the results of 22 trials reporting 24 comparisons. Regarding four-layer compression versus SSB, the review concludes that: Multi-layered high compression was more effective than single-layer. A high compression stocking plus a thrombo stocking is more effective than the SSB system.

Author	Iglesias C, Nelson EA, Cullum NA, Torgerson DJ
Title	VenUS1: a randomized trial of two types of bandage for treating venous leg ulcers.
Reference	Health Technol Assess 8(29):iii 1-105 2004
Summary	A good health economic analysis comparing healing time and rates, and the cost of healing for a four-layer system and a short-stretch bandage system. 387 patients were randomised to either 4 layer bandaging (many different systems) or SSB (many different types). At 12 weeks there was no significant difference in healing between the two systems: 46% vs 37%. At 24 weeks healing rates were significantly different: 68% and 55%. Time to healing was shorter in the 4LB group: 92 days vs 126 days and the SSB system cost over £270 more per patient per year. Patients were unable to wash the SSB as recommended by manufacturers, which added to the cost. Finally, more patients withdrew from the SSB group. This was a well-powered study and, unlike many of the other comparative studies, bias was reduced by ensuring that bandage applicators received thorough training in both systems.

Author	Carr L, Philips Z, Posnett J.
Title	Comparative cost-effectiveness of four-layer bandaging in the treatment of venous leg ulceration.
Reference	J Wound Care 8(5):243-8 1999
Summary	This study provides excellent cost-effectiveness data for PROFORE and all aspects of treating venous leg ulcers. Using published healing rates a model was used to calculate the cost per patient of treating venous leg ulcers, over the course of one year comparing PROFORE with the Charing Cross System. Very detailed costs of PROFORE and the original Charing Cross system are provided. The authors conclude that although PROFORE was marginally more expensive, if the better healing rates of PROFORE are taken into account, it is a cheaper system. The authors also compared a systematic treatment regimen using PROFORE with usual care (specified as normal saline, NA dressing, gauze padding and compression). The PROFORE system was unambiguously more cost effective due to the reduced frequency of dressing changes and the better healing rates and time to heal with PROFORE. Patient outcomes were improved and annual treatment costs were reduced with PROFORE.

Author	Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LML, Peters J, Brooker CGD
Title	Cost effectiveness of community leg ulcer clinics: randomised controlled trial.
Reference	BMJ 316:487-91 1998
Summary	In this randomised controlled trial with one year follow up, 233 patients were randomised to four-layer bandaging in a leg ulcer clinic or standard therapy at home. Ulcers healed faster in the four-layer group, with no significant difference in cost. Although this study provides good evidence that four-layer compression therapy in a dedicated clinic with trained bandagers is a cost-effective way of treating leg ulcers, it is flawed in that it is not possible to separate out the effects of the bandaging system from the place of care.

Author	Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA
Title	Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency.
Reference	J Vasc Surg 30(3):491-8 1999
Summary	This study confirms the efficacy of compression therapy. 252 patients were enrolled prospectively to receive compression and no other adjuvant techniques. Two forms of compression were used for venous ulcers: Unna's Boot (18%) and PROFORE (69%) and three-layer compression for mixed venous-arterial. Healing rates and costs of care were calculated. Healing rates were 57% at 10 weeks and 75% at 16 weeks. Ultimately 96% of ulcers healed. The authors concluded that compression alone without reconstructive surgery or advanced skin products, produces good healing rates at a modest cost.

Author	Moffatt CJ, Simon DA, Franks PJ, Connolly M, Fielden S, Groarke L, McCollum CN
Title	Randomised trial comparing two four-layer bandage systems in the management of chronic leg ulceration.
Reference	Phlebology 14(4):139-42 1999
Summary	A comparison of PROFORE with the original Charing Cross four-layer bandage system. This was a prospective randomised stratified parallel-group open trial on 233 patients to compare PROFORE with the original 4LB bandaging system. Complete healing at 12 weeks was better with PROFORE, but there was no difference at 24 weeks. The authors concluded that ulcer healing was as good with PROFORE as with the original 4LB system.

Author	Marston W, Vowden K
Title	Compression therapy: a guide to safe practice
Reference	EWMA Position Document: Understanding compression therapy. London: MEP Ltd, 11-17 2003
Summary	A good review of published studies on compression itself and the method of compression. Four-layer bandaging whether elastic or inelastic (eg SSB) both provide good compression, but four-layer compression is better if the patient is not mobile. The SSB system relies on the resistance of the bandage against the patient's working calf muscle in order to be effective so is less useful if the patient is not mobile. Also, it does not adjust to changes in shape of the leg. But the reviewers conclude that the SSB system probably has more effect than four-layer bandaging on deep veins.

Author	Danielsen L, Maden SM, Henriksen L, Sindrup J, Petersen L
Title	Sub-bandage pressure measurements comparing a long-stretch with a short-stretch compression bandage.
Reference	Acta Derm Venerol 78:201-4 1998
Summary	One of the few studies which found statistically significant differences between the two systems. 43 patients with venous leg ulcers were randomised to long or short stretch bandages. Pressures were measured at rest and while walking for up to one year. Long-stretch bandages maintained significantly higher pressure in the upright position, sitting and walking than did SSB after 2 and 24 hours. In contrast to generally held opinion, the SSB did not produce higher peak pressures during working of the calf muscles.

Author	Barlow J
Title	Prescribing for leg ulcers in general practice, part 2.
Reference	J Wound Care 8(8):390-4 1999
Summary	This study provides valuable information as to who makes decisions about product selection in the management of leg ulcers and what factors influence those decisions. The authors conclude that the majority of decisions are made by practice and district nurses and patient comfort and compliance are the most important factors in their choice. Nurses do not use the best available evidence because of lack of time to search literature and lack of resources.

Author	Mayberry J-C, Moneta GL, Taylor LM Jr, Porter JM
Title	Fifteen-year results of ambulatory compression therapy for chronic venous ulcers.
Reference	Surgery 109:575-81 1991
Summary	A study which provides important information about factors affecting compliance with compression therapy. A retrospective review of data on 113 patients. Mean time to healing was 5.3 months and complete ulcer healing overall occurred in 97% of compliant patients, but in only 55% of those who were non-compliant with therapy. Total ulcer recurrence was 16% in compliant patients and 100% in non-compliant.

References

¹ O’Meara S, Tierney J, Cullum N, B Either display as MA abstract 2007.

² Moffat C J, et al (1999) Phlebology, 14, 139-142. Randomised Trial comparing Two Four Layer Bandage Systems in the Management of Chronic Leg Ulceration.

Brugsvejledning

Denne information er rettet til professionelt plejepersonale.

Anlæg kun PROFORE efter oplæring i brug og med viden om brugen af kompressionsbehandling til patienter med kompromitteret arterielt kredsløb.

PROFORE er kun til engangsbrug.

Trinvis vejledning til 18-25 cm kit

INDEN ANLÆGGELSE AF FØRSTE BIND er det vigtigt at kontrollere følgende:

Patienten skal undersøges omhyggeligt for at udelukke arteriel sufficiens før brug af kompressionsbehandling. Det anbefales at bruge Doppler-ultralyd. Ankel: ABPI (Ankle Brachial Pressure Index) skal være over 0,8.
Mål ankelomkredsen for at bekræfte, at den er mere end 18 cm (med polstring).
Kontrollér, om patientens ankelomkreds har ændret sig pga. reduktion af ødemet. Mål altid ankelomkredsen igen efter den indledende behandlingsperiode, og se guiden til bandagevalg for at finde det korrekte kit til denne benstørrelse
Undersøg patientens ben for knoglefremspring eller lægfibrose. Sørg for at beskytte disse godt ved brug af PFOFORE #1-polstringen, sådan at trykket fordeles jævnt.

Anlæg PROFORE i følgende rækkefølge:

Trin 1:
PROFORE WCL Sterilt sårkontaktlag
Må ikke anvendes hvis posen er åben eller beskadiget. Tag det ud af pakken med en steril tang og læg det på såret. Hold det på plads, indtil det dækkes med PROFORE #1.

Trin 2:
PROFORE #1 absorberende polstringsbind
Anlæg bindet på foden ved brug af en ankellås. Anlæg fra ankel til knæ ved brug af simpel spiralteknik med 50% overlapning. Undgår at stramme.

Trin 3:
PROFORE #2 let, formbart bind
Anlæg bindet på foden ved brug af en ankellås. Anlæg fra ankel til knæ over PROFORE #1 ved brug af simpel spiralteknik, medium stræk og 50 % overlapning. Brug tape til fiksering.

Trin 4:
PROFORE #3 let kompressionsbind
Anlæg bindet på foden ved brug af en ankellås. Anlæg fra ankel til knæ ved brug af ottetalsmønster med 50% stræk. Brug midterlinjen som rettesnor. Brug tape til fiksering.

Step 5:
PROFORE #4 fleksibelt selvklæbende bind
Anlæg bindet på foden ved brug af en ankellås. Anlæg fra ankel til knæ ved brug af spiralteknik med 50 % stræk og 50 % overlapning. Tryk let ned på bindet for at sikre, at bindet klæber ordentligt fast til sig selv.

Ofte stillede spørgsmål

Ofte stillede spørgsmål om PROFORE

Hvad er PROFORE?

PROFORE er en flerlags kompressionsbandage bestående af 5 komponenter: et sterilt sårkontaktlag, et polstringsbind, et let, formbart bind, et let kompressionsbind og et fleksibelt selvklæbende bind.

Hvor meget kompression tilfører PROFORE?

Det er den gængse opfattelse, at den optimale kompressionsbehandling opnårs med et sub-bandagetryk på 40 mm Hg ved anklen. Dette er blevet benchmark-trykket for kompressionsbind.

PROFORE har til formål at give et fast tryk på 40 mm Hg ved ankelområdet, der gradvis reduceres til 17 mm Hg ved knæet. Det fås i 4 kompressionsstyrker til forskellige ankelstørrelser.

Hvordan heler kompressionen et bensår?

Kompression er med til at reversere veneinsufficiensen i benet, hele eventuel beskadigelse og hjælpe med at dirigere blodgennemstrømningen tilbage mod hjertet.

Hvilke sårkontaktlag kan bruges under PROFORE?

PROFORE er udformet til at virke med PROFORE WCL (TRICOTEX*), et sårkontaktlag med lav klæbetendens bestående af et enkelt lag vævet, let viskose.

Kan PROFORE anvendes på patienter, hvis anamnese inkluderer DVT?

Det er usandsynligt, at kompression vil påvirke de dybe vener, og kompression er derfor ikke kontraindiceret. Elastisk kompression betragtes som et uundværligt komplement til antikoagulationsbehandling ved DVT. Venøs insufficiens er en risikofaktor for DVT. Kompressionsbehandling forbedrer denne tilstand.

Indeholder PROFORE latex?

Ja, standardkittet indeholder latex. Der findes dog latexfri kit til alle ankelstørrelser og kompressionsvarianter, som er fremstillet specifikt uden latex.

Indeholder PROFORE Latexfri stoffer, som kan forårsage allergiske reaktioner?

Nej PROFORE Latexfri indeholder ingen kendte allergener, som f.eks. kolofonium, thiuram og carbamat. Men for at være på den sikre side anbefales patch test inden brug.

Hvad er holdbarheden for PROFORE?

Holdbarheden for PROFORE er 3 år.

Hvordan er PROFORE WCL steriliseret?

PROFORE WCL (TRICOTEX) er steriliseret ved brug af gammastråling.

Hvor lang tid kan PROFORE bæres?

PROFORE kan bæres i op til 7 dage afhængigt af sårets ekssudatniveau. Det kan i begyndelsen af behandlingen være nødvendigt at skifte bandage to gange om ugen.

PROFORE Lite leverer 23mm Hg tryk og kan bæres på benet i op til 7 dage.

Hvornår bør jeg bruge PROFORE?

PROFORE skal bruges på venøse bensår og associerede tilstande.

Hvorfor fås PROFORE i 4 kitstørrelser?

PROFORE er udformet til at give det rette kompressionsniveau til alle ankelstørrelser. De fleste almindelige bind findes kun i en størrelse. På tykkere ankler vil det tryk, der leveres af disse bind, være mindre end det ideelle 40mm Hg.

PROFORE fås i 4 størrelser for at sikre, at ankelstørrelsen modtager netop det korrekte kompressionsniveau.

Hvordan skriver jeg en recept på PROFORE og hvad medfølger i hvert kit?

Kit <18cm ankel omkreds="PROFORE" #1(x2), #2, #3, #4 og wcl>
Kit 18 - 25cm ankel omkreds = PROFORE #1, #2, #3, #4 og WCL
Kit 25 - 30cm ankel omkreds = PROFORE #1, #4, + og WCL
Kit > 30cm ankel omkredse = PROFORE #1, #3, #4, + og WCL
PROFORE Lite = PROFORE#1, #2, #4 og WCL

Kittene kna nu også ordineres som ovenfor

Hvorfor anlægges tredje lag i 8-talsmønster?

Denne teknik sikrer, at de underliggende lag holdes på plads og at der tilføres det korrekte trykniveau til benet.

Hvorfor bruges der ikke 8-talsmønster til anlæggelse af alle bindene?

Når bindene krydser over tibia, øges det lokaliserede tryk på knoglen, hvilket kan forårsage trykskade.

Skal anklen måles før eller efter polstring med PROFORE #1?

Hvis benet er meget tyndt, skal det måles både før og efter polstring for at sikre korrekt kitvalg. Hvis anklen for eksempel måler 15 cm før polstring men 18 cm efter polstring, skal du bruge 18-25 cm kittet. Jo tyndere et ben er, jo større tryk tilføres der.

Hvorfor glider bindet ned mellem anlæggelser?

Kontrollér om bindet er lagt med korrekt stræk. Hvis det ikke er stramt nok øverst på benet, vil det glide ned. Sørg for at polstringslaget er brugt til at opnå en gradueret benfacon som basis for bandageanlæggelsen.

Hvordan tolererer patienter PROFORE?

Den hurtige forbedring af det venøse tilbageløb, som skyldes det konstante, graduerede tryk, mindsker den interne spænding i benet og giver en lettende følelse. Derfor er patienttolerancen meget høj.

PROFORE Products