Cavity wounds management: a multicentre pilot study.

pilot study

Cavity wounds management: a multicentre pilot study Sylvie Meaume, Olivier Facy, Nicolas Munoz-Bongrand, Annie-Claude Ribemont, Michèle-Léa Sigal, Jean-Claude Couffinhal, Chloë Trial, Olivier Tacca, Serge Bohbot

C

© 2013 MA Healthcare Ltd

avity wounds with substance loss (for example, open surgical wounds, chronic wounds such as deep pressure ulcers or diabetic foot ulcers), even when properly treated (for instance, following appropriate debridement, infection control and/or pressure relief) may not heal, as expected (Cannavo et al, 1998). Managing these complex wounds with the appropriate dressing may provide rapid wound closure by secondary intention in order to prevent local infection or further complications and to shorten a hospital stay (Foster et al, 2000; Cohn et al, 2004). Unlike superficial wounds for which dressings are easy to apply and remove, cavity wounds are difficult to manage because of their depth and subcutaneous scaffold structures. Any dressing needs to follow the anatomic contours of the wound to ensure effective absorption of exudate, bacteria and necrotic debris; it therefore requires a dressing that can conform to the shape of the wound and a rope or ribbon-type dressing would appear to be the most suitable option (Dealey, 1989; Dawson et al, 1992; Williams et al, 1995). Gauze dressings (or ribbon gauze) soaked with saline solution or antiseptics are still widely used by surgeons to debride and stimulate granulation of wounds such as open surgical wounds (Miller et al, 1993; Williams et al, 1995; Foster et al, 2000). There is a lack of clear clinical evidence to manage this type of wound. Gauze dressings are not ideal as they adhere to the wound bed and the healing process may be delayed due to the poor acceptability in relation to pain at removal (Cohn et al, 2004; Dealey, 1989; Dinah and Adhikari, 2006). Various clinical trials have shown the benefits of alginates and hydrofibre dressings, in terms of efficacy and/or acceptability versus gauze (or ribbon) dressings in the local Sylvie Meaume is Head of Dermato-geriatric Department, University Hospital Charles Foix, Paris; Olivier Facy, Digestive, Thoracic and Oncology Surgery Department, Bocage University Hospital, Dijon; Nicolas Munoz-Bongrand, General Surgery Department, Saint Louis Hospital, Paris; Annie-Claude Ribemont, Geriatric Department, Dupuytren Hospital, Draveil; Michèle-Léa Sigal, Head of the Dermatology Department, Victor Dupouy Hospital, Argenteuil; Jean-Claude Couffinhal, Head of the Vascular Surgery Department, Victor Dupouy Hospital, Argenteuil; Chloë Trial, Wound Healing Unit Department, Lapeyronie University Hospital, Montpellier; Olivier Tacca, Clinical Research Department, Laboratoires URGO, Chenôve; Serge Bohbot is Medical Director, Laboratoires URGO Accepted for publication: July 2013

British Journal of Nursing, 2013 (Tissue Viability Supplement), Vol 22, No 15

Abstract

The objective of this study was to assess acceptability (based on pain at removal), efficacy and tolerance of an absorbent and cohesive rope (UrgoClean Rope, Laboratoires Urgo) in the local management of deep cavity wounds. This study was a prospective, multicentre (13), noncomparative clinical study. Patients presenting with an acute or chronic non-infected cavity wound were followed up for four weeks and assessed weekly with a physical examination, in addition to volumetric, planimetric and photographic evaluations. Pain at removal was the primary criterion, assessed on a Visual Analogic Scale. The percentage of the wound surface area reduction and volumetric reduction were considered as secondary efficacy criteria. Forty three patients were included in this study. After one week of treatment dressing removal was painless and continued to be so throughout the period of the trial (four weeks). Median surface area at baseline was 7.74 cm² and was reduced by 54.5% at week 4 (relative area reduction). Median wound volumetric value was noted 12 ml at baseline and was reduced by 72.7% by the end of treatment. The cohesiveness of the new rope was considered very good by health professionals. No residue was observed on the wound bed during the dressing change with the new rope. There were no adverse events related to the tested rope, during this trial. Pain-free removal associated with good efficacy and tolerance were observed with this new cohesive rope in the healing process of deep cavity wounds and could represent a therapeutic alternative to the usual ropes used in such indications. Key words: Cavity wound

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Multicentre clinical trial

■

Cohesive rope

management of cavity wounds. Importantly, they are less painful at removal, causing less discomfort for the patients (Miller et al, 1993; Cannavo et al, 1998; Cohn et al, 2004; Williams et al, 2005). These dressings, which are indicated to manage exuding wounds, are able to absorb exudates while maintaining a moist wound environment conducive to promoting the healing process, as described by Winter in 1962 (Winter, 1962; Winter and Scales, 1963). These two types of dressings have demonstrated similar performances in the healing process, in both acute (Foster et al, 2000) and chronic wounds (Harding et al, 2001). However, they may break up at removal, leaving residues in the cavity wound. If this happens, the fibres are most often easily irrigated out with normal saline (Williams et al, 1995; Limová, 2003). In a move to improve the management of these acute or chronic cavity wounds, Laboratoires URGO’s research department has developed a highly absorbent new dressing, UrgoClean® rope, composed of cohesive polyacrylate

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British Journal of Nursing. Downloaded from magonlinelibrary.com by 139.080.123.049 on November 14, 2015. For personal use only. No other uses without permission. . All rights reserved.

Material and methods This multicentre, non-comparative trial was conducted openlabel in France, including 43 adult patients, both hospitalised or outpatients (or patients hospitalised then treated as outpatients) from different surgical units (general, vascular, plastic and reconstructive surgery or burns departments) and geriatric wards. These patients were presenting an acute (for example, open surgical wound, suture failure, dehiscence) or chronic (stage 3 or 4 deep pressure ulcer according to the European Pressure Ulcer Advisory Panel classification) cavity wound, requiring a rope-type dressing for their local management. Patients were recruited through 13 active investigating centres after they provided their written informed consent and agreed to be followed up by the same investigating team on a weekly basis for the four weeks study duration. Patients presenting with a systemic infection uncontrolled by appropriate antibiotics, presenting a wound entirely or partially covered by black necrotic tissue, a dry or a clinically infected wound, or a malignant wound, were excluded. The recruited patients were treated with the trial product (UrgoClean® rope coded URGO 310 3131 in this trial) for a maximum period of four weeks (or until healing occurred). A clinical assessment was undertaken by the investigating physician on a weekly basis that included pain evaluation using a Visual Analogic Scale (VAS). A wound-area tracing (done with a transparent film under a standard procedure provided by the sponsor, if applicable), a volumetric measurement (if applicable) and a record of any local adverse event were also undertaken. For the volumetric measurement, the wound was covered with a transparent adhesive film and then saline solution was injected with a needle, to fill the cavity. The volume of saline required to fill the wound was then recorded and the length of the rope used to fill the cavity wound was also measured over time. Every dressings change was documented in the Medical Case Report Form (CRF) during the investigator’s weekly visits scheduled in the protocol and in the Nursing Followup Notebook when done between two-weekly evaluations. The change frequency was left to the convenience of the investigator, depending on the clinical aspect of the wound and exudate volume.

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The dressing acceptability was assessed by the patients and nurses at every dressing change on a four-point scale for the following parameters: ■■ Ease of application ■■ Ease of removal ■■ Conformability to the wound bed ■■ Adherence to the wound bed ■■ Bleeding on removal ■■ Cohesiveness of the rope.

Endpoints The primary endpoint of this trial was the pain experienced on removal of the rope dressing when used in the local treatment of acute and chronic cavity wounds. The intensity of pain was measured on a VAS during clinical assessments, scheduled in the protocol, for the whole treatment period. The VAS was related to a Simple Verbal Rating Scale (SVRS) made up of a list of five adjectives placed in increasing order of intensity (no pain, mild pain, moderate pain, severe pain, unbearable pain). VAS results were divided into the following categories such that they could be combined with the SVRS results: ■■ 0-10 mm: no pain ■■ 10-30 mm: mild pain ■■ 30-50 mm: moderate pain ■■ 50-70 mm: severe pain ■■ 70-100 mm: pain as bad as it can be. Secondary endpoints regarding the healing process were documented through volumetric measurements (if applicable), surface area tracings (if applicable) and measurement of the rope length to fill the cavity. Other secondary endpoints were documented, like the clinical evolution of the wounds

43 patients matching the inclusion/exclusion criteria were included in the trial 6 patients prematurely discontinued the study treatment

4 because of a serious adverse event° 2 because of ‘other reasons’°°

1 patient with complete closure before week 4 2 patients stopped tested treatment because it was deemed unsuitable°°° 34 patients completed the four-week study without complete closure Figure 1. Patient’s distribution ° Abscess/acute peritonitis/intestinal occlusion/haemorrhage °° Transfer to a rehabilitation centre without possible follow-up/patient left town °°°No more cavity. Use of a contact layer, though the patient was followed until week 4 to evaluate the wound depth and size


fibres. Its clinical efficacy was recently documented on chronic wounds (Meaume et al, 2012) and seems to be, at least, similar to those reported in clinical literature when considering the use of alginate/hydrofibre dressings in such wounds (Limová, 2003; Wild et al, 2010). In addition, its high tensile strength with a one-piece removal leaving no residue on the wound bed was documented in a previous clinical study (Meaume et al, 2012). This might be of real benefit in the local management of cavity wounds, providing straightforward dressing changes, when used with a suitable adapted format (rope). This pilot study was conducted to evaluate pain at removal, efficacy and acceptability (notably removal in a single piece) of the new UrgoClean rope format dressing in the local treatment of acute and chronic cavity wounds.



Ethical considerations

Acute wounds N = 37

Chronic wounds N=6

Total N = 43

Gender Female Male

13 (35.1%) 24 (64.9%)

6 (100%)

13 (30.2%) 30 (69.8%)

Age (years) (Mean ± SD) (Min; max) Median

66.8 ± 21 [18 ; 97] 72

45.5 ± 24.4 [17* ; 82] 40

63.8 ± 22.4 [17* ; 97] 70

Body weight (kg) (Mean ± SD) (Min; max) Median

76.8 ± 16.6 [40 ; 117] 79

85 ± 25.1 [70 ; 135] 75

78 ± 17.9 [40 ; 135] 79

Height (cm) (Mean ± SD) (Min; max) Median

170.7 ± 8.9 [150 ; 185] 170

175.5 ± 7.2 [165 ; 185] 176.5

171.4 ± 8.8 [150 ; 185] 172

BMI (kg/m2) (Mean ± SD) (Min; max) Median

26.5 ± 6.2 [14.7 ; 43.8] 25.6

27.7 ± 8.3 [22.1 ; 44.1] 25.2

26.7 ± 6.4 [14.7 ; 44.1] 25.6

Hypertension (HBP)

13 (35.1%)

2 (33.3%)

15 (34.9%)

Cardiac disease

13 (35.1%)

1 (16.7%)

14 (32.6%)

Diabetes mellitus

6 (16.2%)

1 (16.7%)

7 (16.3%)

*Patient was aged under 18 years old during the trial, therefore parents gave their consent to participate in clinical trial Table 2. Baseline wounds’ characteristics Acute wounds N = 37

Chronic wounds N=6

Total N = 43

Wound duration (days) (Mean ± SD) (Min; max) Median

n=33 22.4 ± 18.9 [1 ; 70] 18

n=6 336.8 ± 431.9 [30 ; 1065] 106.5

n=39 70.7±195.1 [1 ; 1065] 21

Surface area(cm²) (Mean ± SD) (Min; max) Median

n=33 21.6 ± 30.4 [0.4 ; 144] 10

n=6 8.8 ± 12.4 [1.5 ; 33.5] 3.2

n=39 19.7±28.7 [0.4 ; 144] 9.3

Volume of cavity wound (ml) (Mean ± SD) (Min; max) Median

n=21 21.7 ± 19.2 [1 ; 70] 14

n=3 7 ± 1.7 [5 ; 8] 8

n=24 19.9 ± 18.6 [1; 70] 12

Condition of the surrounding skin - Healthy - Not healthy

29 (78.4%) 8 (21.6%)

4 (66.7%) 2 (33.3%)

33 (76.7%) 10 (23.3%)

n=4 95 ± 5.5 [90 ; 100] 95

n=40 73.6 ± 37.4 [0 ; 100] 90

Granulation tissue on the wound bed (%) n=36 (Mean ± SD) 69.9 ± 39.4 (Min; max) [0 ; 100] Median 90

(percentage of granulation tissue covering the wound cavity bed), local tolerance of the rope (occurrence of local adverse events), and the acceptability of the dressing by the patients and the nursing staff, including the pain at removal on the SVRS at each care operation .

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This clinical trial was conducted according to the European GCP recommendations; the principles of the declaration of Helsinki (1975) and the current French-specific regulations. Laboratoires URGO started the trial after approval from the French Agency for the Safety of Health Products and approval of the French Medical Ethics Committee of Paris Ile de France VIII on 2 February 2010. At baseline and before being included in the trial, each patient received a full debrief verbally and in writing on the study objectives and the expected benefits and gave his or her written consent before the initiation of the treatment with the tested rope.

Statistical analysis Data management, wound areas measurements and statistical analysis of this trial were conducted by a company independent from the sponsor (Clinical Research Organisation: Altizem. Nanterre), in accordance with the statistical analysis plan written before the start of the trial. Given that this clinical trial was a pilot and regarding the data available in the literature concerning the local treatment of cavity wounds, it appeared that a total number of 40 patients (i.e.. several hundred dressing changes), should be sufficient to provide a pertinent and acceptable measurement of the primary endpoint. An intention to treat (ITT) analysis was undertaken on the whole population of the trial; all enrolled patient was included in the primary and secondary endpoints analysis, which were purely descriptive (no statistical test was performed), including the occurrence of local adverse events, fully documented. The Last Operation Value Carried Forward (LOVCF) method was used for missing data, when necessary and variables were summarised by their mean, standard deviation, median and range.

Tested rope UrgoClean® rope dressing is made up of a non-woven gel-blocking compress based on highly absorbent, thermalbonded fibres that form a hydrogel when they come into contact with exudate. As this hydrogel has a high integrity, the rope can be removed without breaking up, leaving no residue in the wound.The dressing comes in the form of a single-size, non-absorbable rope 5 cm wide and 40 cm long. The frequency of dressing changes depends on wound condition and the volume of exudate produced. As a rough guide, the dressing was to be changed every 1–2 days. However, rope-changing frequency was left to the discretion of the investigating team and depended on wound condition. The number of ropes used to treat the wound may vary in relation to the depth of the cavity. Saline solution (0.9%) was recommended for local care. Mechanical cleansing could be combined with the trial dressing if considered necessary to promote wound healing. Any such use was to be recorded by nursing staff in the Medical CRF and/or the Nursing Follow-up Notebook.

Results Forty three patients presenting with an acute (37) or chronic (6) cavity wound were included in this clinical trial through 13 active investigating centres in France.


Table 1. Baseline patients’* characteristics



pilot study As noted in the patients’ distribution (Figure 1), 35 patients (81%) were treated up to week 4 or to healing with the tested rope; the other patients (8/43) prematurely discontinued the studied treatment (occurrence of adverse event or treatment deemed unsuitable and then switched to another local treatment). The vast majority of patients (36/43: 83.7%) recruited in this study were hospitalised and the mean time of study participation for each patient was similar in both groups whether acute or chronic (25 days, with a median time of 29 days). The majority of patients included in the trial were male, with a mean age of 63.8 years and presenting as overweight. Most of the acute cavity wounds were post-operative (89%), mainly located on the abdomen and lower limbs with others, post-traumatic. The chronic wounds were stage 3 and 4 deep pressure ulcers, located on the pelvic area. The main wounds’ baseline characteristics are presented in Table 2. At baseline, the wounds were widely recovered by a granulation tissue with healthy surrounding skin and the surface area and volume were measured when applicable (regular cavity wound without undermining). The volume was measured in 24 patients (mean values of 21 ml and 7 ml in the acute and chronic wounds group, respectively) and the mean surface area (39/43 patients) was 21.6 and 8.8 cm² in the acute and chronic groups, respectively. Four of the 43 patients received the tested rope as a firstline treatment. At baseline, the other patients were already undergoing treatment for their cavity wounds; alginate dressings (dressing or rope) were mainly used (61.2%) in addition to greasy gauze or contact layers.

VAS-SVRS combined score 100 90

86.5

80 70

70.3

60 50 40 30 20 10 0

D0

W2

W1

Baseline dressing removal (with the previous dressings) for all wounds (acute and chronic) induced little pain (mean value of 5.8 mm on the VAS), which decreased during the trial to 1.2 mm (week1), 0.7 (week 2), 0.9 (week 3) and to 0 at week 4. If the VAS-SVRS combined score over the follow-up period is examined, the following elements become apparent: at baseline, no pain (0-10mm) for 70.3% of the patients, which progressed over the treatment period as follows: 89.7% at week 1, 86.5% at week 2, 93.9% at week 3 and 97.1% at week 4, as reported in Figure 2.


Secondary end points The healing process evaluation included a wound volume assessment (measured by injecting saline in the cavity wound) and standard surface area measurements (using planimetrics—a transparent sterile sheet used to draw on the area). The wound’s volume follow-up was documented for 21 wounds (only possible when the cavity wound was a regular one, without any undermining) and was noted on a weekly basis, over the four weeks of treatment with the tested rope. The baseline mean wound volume was 18.9 ml (median: 12 ml) and decreased to a mean volume of 5.11 ml (median: 2 ml) after the treatment period. The weekly decrease of the cavity wound volume (reported in Figure 3) following four weeks’ treatment reached 72.7%, compared with baseline. This decrease in volume corresponds


W3

W4

No pain [0mm - 10mm] Figure 2 – VAS-SVRS: Combined score over the four-week follow-up period, for all wounds. W=week.

Relative changes in wound volume 0 -10 -20 -30

W1

W2

W3

W4

-69.71

-72.71

-29.17

-40

-49.29

-50 -60

Primary end point: the pain at removal

97.1

93.9

89.7

-70 -80 -90 -100

Change in volume over time relative to D0, in % Figure 3 – Relative wound volume reduction over the four-week follow-up period (median value)

Relative decrease of wound surface area (%) 0

W1

W2

W3

W4

-49.62

-54.56

-10 -14.04 -20 -30 -40

-31.01

-50 -60 Relative decrease of wound surface area Figure 4 – Relative wound surface area reduction over the four-week follow-up period

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Table 3. Dressing change acceptability Chronic wounds Total N=133 N = 668

Ease of application n (%) Very easy Easy Difficult Very difficult

n=514 340 (66.1) 169 (32.9) 5 (1) -

n=131 106 (80.9) 25 (19.1) -

n=645 446 (69.1) 194 (30.1) 5 (0.8) -

Conformability n (%) Very good Good Poor Very poor

n=511 338 (66.1) 173 (33.9) -

n=124 85 (68.5) 39 (31.5) -

n=635 423 (66.6) 212 (33.4) -

Ease of removal n (%) Very easy Easy Difficult Very difficult

n=510 369 (72.4) 133 (26.1) 8 (1.6) -

n=124 112 (90.3) 12 (9.7) -

n=634 481 (75.9) 145 (22.9) 8 (1.3) -

Rope totally cohesive at removal Yes No

n=488 422 (86.5) 66 (13.5)

n=129 87 (67.4) 42 (32.6)

n=617 509 (84.3) 102 (15.7)

Adherence to the wound bed n (%) None Moderate Marked Very marked

n=525

n=130

n=655

387 (73.7) 126 (24) 12 (2.3) -

121 (93.1) 9 (6.9) -

508 (77.6) 135 (20.6) 12 (1.8) -

Bleeding at removal n (%) None Moderate Marked Very marked

n=523 424 (81.1) 94 (18) 5 (1) -

n=129 105 (81.4) 22 (17.1) 2 (1.6) -

n=652 529 (81.1) 116 (17.8) 7 (1.1) -

to a major filling of the wounds and can be correlated to the length of rope used during dressing change to fill the wound; rope length decreased over time, from 40 cm at baseline to 13.5 cm at week 3. The wound surface area was measured at baseline for 36 of the 43 included patients, as for 6 patients, there was no notable surface (because of a simple linear incision) and the noted median surface area was 7.74cm² and was noted to be 3.2cm² after 4 weeks of treatment with the study rope. The median reductions in surface area over the 4-week treatment period are reported in Figure 4, reaching 54.6% reduction when compared with baseline, at the entry in the study.

Acceptability In total, 668 dressing changes were documented during this clinical trial; 148 of them were documented in the Medical CRFs and the other 520 were documented in the Nursing Follow-up Notebooks, between the weekly visits scheduled in the protocol, at a dressing change, every 1–2 days. Table 3 presents the elements for each of the evaluated acceptability parameters. As noted by the health professionals and the patients throughout the hundreds of dressing changes, the tested rope was always considered to be easy or very easy to apply or to remove, in one piece, with good conformability to the cavity wound. Rope adherence to the wound bed on removal, was deemed ‘absent’ (77.6%) or ‘moderate’ (20.6%) in 98.2% of the dressing changes and it remained in one piece (no residue in the cavity wound) when removed in 82.5% of changes. Some rope fibres then left in the wound were removed simply by rinsing the cavity wound with saline solution.

Local adverse event (LAE) The investigating physicians evaluated the local tolerance at each weekly visit scheduled in the protocol for the four-week follow-up period, based on the occurrence of the LAE. One LAE (bleeding of surgical wound) was reported during this trial. This event was deemed ‘unrelated’ to the medical device. This LAE led to temporary discontinuation (one day) of rope dressing treatment. So, we can consider, regarding the number of cumulated days of treatment, that the UrgoClean® rope presents a good safety profile.

Discussion Most acute surgical cavity wounds cannot be closed with sutures or clips due to contamination or infection and so are left open to heal by secondary intention (Moore and Foster, 1998). They are traditionally packed with a simple dressing such as ribbon gauze, which can be very painful for the patient on removal (Dealy, 1989). They do not always achieve optimal healing like modern dressings, as they can damage the newly formed granulation tissue. Dressings appear to offer a better alternative (Foster et al, 2000) through their pain-free and atraumatic removal. Among them, hydrofibre dressings used on surgical wounds


Acute wounds N=535

Figure 5 – Differences in wound appearance over a three-week period

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pilot study has shown a significant reduction of pain level at the first dressing change compared with ribbon gauze soaked with antiseptic (p=0.002), which routinely required analgesia before removal of the dressing (Foster and Moore, 1997). These elements are supported by previous clinical data on deep open surgical wounds; this hydrofibre dressing showed a higher healing rate when compared with wet-to-dry gauze in the control group, without reaching, however, a significant level (p=ns) (Cohn et al, 2004). Alginate fibres could represent a more acceptable alternative to soaked gauze in the management of open cavity wounds or surgical wounds due to their ease of application and painless removal (Dawson et al, 1992; Cannavo et al, 1998; Miller et al, 1993). In addition, it has been suggested that alginate dressings promote wound healing (Sayag et al, 1996; Belmin et al, 2002; Thomas, 2000). These two types of dressings, despite their benefits (painless removal and good acceptability) sometimes present a lack of cohesiveness and may break up on removal leaving residue on the wound bed (Dealy, 1989; Harding et al, 2001; Limová, 2003). In response to this, the research department of Laboratoires Urgo has developed a new absorbent, cohesive fibre, which could be used by health professionals in the management of open cavity wounds A pilot clinical trial was undertaken to evaluate the pain at removal as a primary objective, in addition to efficacy, acceptability and tolerance of the UrgoClean® rope in the local care of acute and chronic cavity and anfractuous wounds, left to heal by secondary intention. Pain at removal was considered as the most relevant primary criterion, as it represents the main drawback of the ribbon gauze, still widely used in this type of wound, this criteria being probably related to their tendency to adhere to the wound bed (Dawson and Armstrong, 1992). The VAS is currently the most pertinent method for the pain evaluation regarding reliability and validity (Sriwatanakul et al, 1983; Scott and Huskisson, 1979). The 43 patients involved in this trial were treated for a maximum of four weeks and assessed on a weekly basis. The analysis of the clinical trial’s primary endpoint showed that very quickly, after only one week of treatment with the tested rope, the removal was painless (mean value 1.2 mm on the VAS vs 5.8 mm at baseline). In addition, the analysis of the combined VAS-SVRS score confirmed this painless removal (no pain experienced in 89% at week 1 vs 70% at baseline). Without any control group in this open trial, and only very limited clinical data in the literature to make indirect comparisons with those documented in this trial, performance of the tested rope regarding pain at removal seems to be at least similar to those previously reported with alginates or hydofibres in such indications (Dawson and Armstrong, 1992; Cannavo et al, 1998; Foster et al, 2000). This can be considered as the main study limitation. Wound volume and surface area assessments were performed when applicable. Cavity wounds with undermining or linear surgical incisions to be healed by secondary intention were excluded from the analysis of these secondary endpoints. Wound volume decreased to a median value of 2 ml at


Key points n UrgoClean rope, composed of polyacrylate fibres, is specifically dedicated to acute or chronic cavity wounds management n A good acceptability for the patients (pain-free removal in addition to a good safety profile) and for the nursing staff (one-piece removal) were documented in this clinical trial n Its specific properties (cohesiveness at removal and high absorption capacity) and benefits allow this rope to represent an alternative to conventional ribbon gauze or other ropes

week 4 vs 12 ml at baseline (72.7% relative reduction) while the median surface area, which partially reflects the clinical course of cavity wounds (as wound filling precedes wound closure), decreased from 7.74 cm² at baseline to 3.21 cm² after four weeks of treatment (54.5% relative reduction). Without a control group, it is difficult to draw conclusions, but these results seem quite positive and the investigating physicians considered that 88.6% of the patients showed a favourable clinical course, in addition to one healed wound during the course of the study. Regarding the acceptability parameters, the rope adherence on removal was deemed ‘none’ or ‘moderate’ in 98.2% of the care operations; accordingly, removal was considered very easy in more than 90% of the cases and it is established than there is a good correlation between ease of removal of the dressing and the pain experienced during the care (Dawson and Armstong, 1992; Letouze et al, 2004; Meaume et al, 2004). Additionally, the tested rope remained totally cohesive on removal in 82.5% during the hundreds of the care operations. The change frequency of the tested rope, every 1–2 days, is similar to that of whichever type of rope, ribbon gauze, alginate or hydofibre (Dearly, 1989; Miller et al, 1993; Cohn et al, 2004), and the analysis of the adverse events that occurred during the trial shows very good tolerance— the only one that was documented was considered by the investigating physician not to be related to the tested rope.

Conclusion The results of this pilot clinical trial, even bearing in mind its open and non-controlled character, show that this new rope seems to present a benefit in the management of acute and chronic cavity wounds. Its painless removal and cohesiveness, in addition to its relative efficacy and good tolerance, should allow this new rope to represent an alternative to other ropes used in these indications. However, these elements have to be confirmed by supportive data through further randomised BJN controlled trials. Conflict of interest: this study was sponsored by a grant from Laboratoires Urgo pharmaceutical company. Belmin J, Meaume S, Rabus MT, Bohbot S (2002) Investigators of the Sequential Treatment of the Elderly with Pressure Sores (STEPS) Trial. Sequential treatment with calcium alginate dressings and hydrocolloid

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dressings accelerates pressure ulcer healing in older subjects: a multicenter randomized trial of sequential versus non-sequential treatment with hydrocolloid dressings alone.J Am Geriatr Soc 50(2): 269-74 Cannavo M, Fairbrother G, Owen D et al (1998) A comparison of dressings in the management of surgical abdominal wounds. J Wound Care 7(2): 57-62 Cohn SM, Lopez PP, Brown M, et al (2004) Open surgical wounds: how does Aquacel compare with wet-to-dry gauze? J Wound Care 13(1): 10-2 Dawson C, Armstrong MW, Fulford SC, et al (1992) Use of calcium alginate to pack abscess cavities: a controlled clinical trial. J R Coll Surg Edinb 37(3): 177-9 Dealey C (1993) Management of cavity wounds. Nursing (Lond) 3(39): 25-7 Dinah F, Adhikari A (2006) Gauze packing of open surgical wounds: empirical or evidence-based practice? Ann R Coll Surg Engl 88(1): 33-6 Foster L, Moore P (1997) The application of a cellulose-based fibre dressing in surgical wounds. J Wound Care 6(10): 469-73 Foster L, Moore P, Clark S (2000) A comparison of hydrofibre and alginate dressings on open acute surgical wounds. J Wound Care 9(9): 442-5 Harding KG, Price P, Robinson B, Thomas S, Hofman D (2001) Cost and dressing evaluation of hydrofiber and alginate dressings in the management of community-based patients with chronic leg ulceration. Wounds 13(6): 229-36 Letouze A, Voinchet V, Hoecht B, Muenter KC, Vives F, Bohbot S (2004) Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies. J Wound Care 13(6): 221-5 Limová M (2003) Evaluation of two calcium alginate dressings in the management of venous ulcers. OstomyWound Manage 49(9): 26-33 Meaume S, Perez J, Rethore V et al (2012) Management of chronic wounds

with an innovative absorbent wound dressing. J Wound Care 21(7): 31522 Meaume S, Téot L, Lazareth I, Martini J, Bohbot S (2004) The importance of pain reduction through dressing selection in routine wound management: the MAPP study. J Wound Care 13(10): 409-13 Miller L, Jones V, Bale S (1993) The use of alginate packing in the management of deep sinuses. J Wound Care 2(5): 262-3 Moore P, Foster L (1998) Acute surgical wound care 1: An overview of treatment. Br J Nurs 7(18): 1101-6 Sayag J, Meaume S, Bohbot S (1996) Healing properties of calcium alginate dressings.J Wound Care 5(8): 357-62 Scott J, Huskisson EC (1979) Vertical or horizontal visual analogue scales. Ann Rheum Dis 38(6): 560 Sriwatanakul K, Kelvie W, Lasagna L et al (1983) Studies with different types of visual analogic scales for measurement of pain. Clin Pharmacol Ther 34(2): 234-9 Thomas S (2000) Alginate dressings in surgery and wound management-Part 1. J Wound Care 9(2) :56-60 Wild T, Eberlin T, Andriessen A (2010) Wound cleansing efficacy of two cellulose-based dressings. Wounds 6(3): 14-21 Williams P, Howells RE, Miller E, et al (1995) A comparison of two alginate dressings used in surgical wounds. J Wound Care 4(4): 170-2 Winter GD (1962) Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature 193:293-4 Winter GD, Scales JT (1963) Effect of air drying and dressings on the surface of a wound. Nature 197: 91-2

Quick reference accident and emergency radiology guide About this book By Chris Harvey, Steve Allen and Declan O’Regan

The purpose of this book is to show how a systematic analysis of accident and emerg ency radiographs allows the correct diagnosis derived while minimising errors. Pocket sized book presents ato besystematic analysis of This book is aimed at accident and emerg ency doctors, surgical, accident and emergency radiographs tomedic assist inlogydiagnosis. al and radio specialist registrars and medical stude nts. This lavishly illustrated pocket sized book facilitates instant consultation when faced with an X-ray. At the start of each chapt er there is a description of the relevant anatomy It contains: followed by a quick and easy yet detail ed systematic approach to all types of X-rays likely to be encountered in the accident and emerg ency department. The book is illustrated with easy to follow line diagrams as well as fully • Descriptions ofativerelevant anatomy annotated illustr examples and is divided into concise chapt ers covering a particular region or problem. In addition to provid ing a systematic approach to the interp retation of the X-ray, tables provide instant access to lists and there are useful tips • A quick, detailed systematic approach to all and hints in avoideasy ing mistakes.yet There is also a list of key points at the end of each chapter. types of X-rays

About the authors

• Illustrations Chris Harvey with easy to follow diagrams BSc(Hons) MBBS MRCP FRCR is Consu

ltant Radiologist, Hammersmith Hospi

tal, London UK

• TablesDecla with access to lists n O’Reginstant an

Accident and Emergency Radiology

Interpretation of plain films

BSc MBBS MRCP FRCR PhD is Senior Lectu

rer, Hammersmith Hospital, Londo

n UK • UsefulStevehints Allen and tips to avoiding mistakes BSc(Hons) MBBS MRCS FRCR is Consu

ltant Radiologist, Royal Marsden Hospi

• Key points at the end of each chapter

tal, London UK

ISBN-13: 978-1-85642-315-1; 210mm x 140mm paperback; 170 page; publication 2009; RRP £19.99

Order your copies by visiting

www.quaybooks.co.uk www.quaybooks.co.uk or call our Hotline +44(0)1722 716 935 9

781856 423151


ISBN 978-1-85642-315-1

Chris Harvey Steve Allen Declan O’Regan

A&E RADIOLOGY.indd 2-3

S34

30/3/09 14:31:1



Healing of cavity wounds.

Healing of cavity wounds.

Healing of cavity wounds with sugar.

The management of wounds.

An analytical study of Mammalian bite wounds requiring inpatient management.

The use of tannins in the local treatment of burn wounds - a pilot study.

Penetrating Wounds of the Abdominal Cavity: Treatment-Recovery.

The local anaesthetic effect of a dental laser prior to cavity preparation: a pilot volunteer study.

The management of shotgun wounds.

Management of penile gunshot wounds.

Moxibustion for the treatment of pressure ulcers: study protocol for a pilot, multicentre, randomised controlled trial.

Metoclopramide for patients with intractable hiccups: a multicentre, randomised, controlled pilot study.

Cognitive Behavioral Therapy for Management of Dyspnea: A Pilot Study.

Management of Discharged Emergency Department Patients with a Primary Diagnosis of Hypertension: A Multicentre Study.

Application of hyaluronic acid in the healing of non-experimental open wounds: A pilot study on 12 wounds in 10 client-owned dogs.

Prevention and management of nonhealing perineal wounds.

Unplanned admissions and the organisational management of heart failure: a multicentre ethnographic, qualitative study.

Hepatitis delta virus testing, epidemiology and management: a multicentre cross-sectional study of patients in London.

Problems in the management of chronic hepatitis B with interferon: experience in a randomized, multicentre study.

Chronic wounds: management of healing and wellbeing.

Management of inoperable malignant oesophageal strictures with fully covered WallFlex(®) stent: a multicentre prospective study.

Trauma airway management in emergency departments: a multicentre, prospective, observational study in Japan.

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study.

Management of paediatric spontaneous pneumothorax: a multicentre retrospective case series.