Elsevier

Injury

Volume 42, Issue 10, October 2011, Pages 1020-1026
Injury

Randomised clinical trial comparing pressure characteristics of pelvic circumferential compression devices in healthy volunteers

https://doi.org/10.1016/j.injury.2010.09.011Get rights and content

Abstract

Introduction

The role of pelvic circumferential compression devices (PCCDs) is to temporarily stabilise a pelvic fracture, reduce the volume and tamponade the bleeding. Tissue damage may occur when PCCDs are left in place longer than a few hours. The aim of this randomised clinical trial was to quantify the pressure at the region of the greater trochanters (GTs) and the sacrum, induced by PCCDs in healthy volunteers.

Materials and methods

In a crossover study, the Pelvic Binder®, SAM-Sling® and T-POD® were applied successively onto 80 healthy participants in random order. The pressure was measured using a pressure mapping system, with the volunteers in supine position on a spine board and on a hospital bed. Data were analysed using Mixed Linear Modelling.

Results

On a spine board, the pressure exceeded the tissue damaging threshold at the GTs and the sacrum. Pressure at the GTs was highest with the Pelvic Binder®, and lowest with the SAM-Sling®. Pressure at the sacrum was highest with the Pelvic Binder®. The pressure at the GTs and sacrum was reduced significantly for all three PCCDs upon transfer to a hospital bed.

Conclusion

The results of this randomised clinical trial in healthy volunteers showed that patients with pelvic fractures, temporarily stabilised with a PCCD, are at risk for developing pressure sores. The pressure on the skin exceeded the tissue damaging threshold and is, besides PCCD type, influenced by BMI, waist size and age. Regardless with which PCCD trauma patients are stabilised, early transfer from the spine board is of key importance to reduce the pressure to a level below the tissue damaging threshold. Clinicians should be aware of the potential deleterious effects associated with the application of a PCCD, and every effort must be made to remove the PCCD once haemodynamic resuscitation has been established.

Introduction

Pelvic ring fractures often result in massive haemorrhage. Related mortality rates range from 5 to 55%, depending on the fracture type and overall injury severity [8], [20]. Fracture reduction and stabilisation reduce the inner pelvic volume and concomitant blood loss, and may tamponade massive venous haemorrhage [13], [26]. Massive haemorrhage in poly-traumatised patients causes hypotension and impaired perfusion of the skin, which enhances local tissue hypoxia, ultimately followed by necrosis [1]. According to the Advanced Trauma Life Support® (ATLS®) guidelines, all patients with suspected pelvic ring injury should receive immediate application of pelvic ring compression [12]. For this purpose, non-invasive pelvic circumferential compression devices (PCCDs) can be applied pre-hospitally, i.e., at the accident scene, or ultimately at the emergency department. PCCDs act as a temporary fixation of the pelvis until surgical fixation interventions can be initiated, or until unstable pelvic fractures are excluded on radiographic examination. PCCDs act by imposing pressure to the pelvis. This pressure also involves the overlying skin, which induces associated risks for developing skin breakdown. In severely injured patients, such as patients with pelvic fractures, these preventable complications should receive early attention.

PCCDs seem to be effective in early stabilisation of unstable pelvic fractures [2], [3], [7], [13], [25]. The results of cadaveric biomechanical studies by Bottlang et al. [2], [3] suggested that, for optimal reduction of open-book pelvic fractures, a pelvic sling should be applied around the greater trochanters and the symphysis pubis and should be tensioned to 180 N. The reduction with a prototype strap at the level of the greater trochanters was characterised by a strap–skin interface pressure of 24 mm Hg (=3.2 kPa) [3]. Clinical data to support that the exerted pressure on the skin with PCCDs would cause adverse effects on skin viability are limited.

Skin damage associated with the use of pelvic binding with various methods and devices, including PCCDs, has been described in a systematic review [25]. Skin breakdown at the level of the symphysis and bilaterally around the greater trochanters (GTs) following circumferential pelvic anti-shock sheeting (folded sheet) was reported by Schaller et al. [23]. This implies the need to avoid over-tightening and prolonged use of pelvic compression over the skin. Krieg et al. [14] reported skin necrosis over the area of PCCD application for a patient with an unstable pelvic ring injury and associated Morel–Lavallee lesion (i.e., closed internal degloving injury). Soft-tissue injury, caused by the initial trauma, frequently accompanies severe pelvic trauma [15], [22]. Jowett and Bowyer [10] studied effects of PCCDs in 10 healthy individuals and reported that the use of PCCDs might carry a risk of pressure sores and additional skin necrosis. However, prospective data concerning influence of PCCDs on morbidity and complications are lacking.

Tissue damage (e.g., pressure sores and skin necrosis) may occur when pressures above 9.3 kPa are sustained continuously for more than 2–3 h [27]. Pressure sores are best seen as potentially preventable complications of acute immobility. Patients suffering from high-energy trauma are often immobilised on spine boards with cervical collars, to prevent aggravation of injuries during transfer to the hospital. Immobilisation is most often continued until diagnostic imaging rules out spinal injury and frequently lasts up to 3 h [16]. Immobilisation on a spine board is a well-known potential risk factor for development of pressure sores [6], [18]. Most of the research on and development of PCCDs focuses on long-term lying comfort on various surfaces [11] and not so much at distribution of pressure at specific sites [9], [24].

The aim of this randomised controlled trial was to quantify the exerted pressures of PCCDs on the skin in a “best case” scenario with healthy volunteers at the region of the GTs and sacrum.

Section snippets

Study design

Eighty healthy volunteers aged 18–70 years, without a history of pelvic or low back problems were enrolled in this randomised clinical trial (Registration number: NTR1214 (http://www.trialregister.nl)). Proportional distribution of volunteers in different BMI strata (<18.5, 18.5–24.9 and ≥25.0 kg/m2) was pursued. Signed informed consent was obtained from each volunteer. The study was performed with approval of the local Medical Ethics Committee.

Three commercially available PCCDs were tested:

Demographic description of study population

A demographic description of the study population is shown in Table 2. The majority of the 80 individuals enrolled, was female (N = 49). Overall, the participants had a mean age of 29 ± 12 years and a BMI of 23 ± 3 kg/m2. There were no statistically significant differences between males and females with respect to age, BMI, and waist size (Table 2).

Each type of PCCD displayed unique pressure characteristics, as shown in Fig. 2. The SAM-Sling® comes in three sizes. In this sample, 70% of the volunteers

Discussion

The PCCDs that were tested in this randomised clinical trial are primarily designed for reduction of the pelvic volume and stabilisation of the bony elements after fracture, thereby reducing haemorrhage. The role of PCCDs is temporary, for transfer and transient situations in the hospital. The pressure needed to accomplish pelvic ring reduction may put the underlying skin at risk of tissue damage. Upon achievement of haemodynamic stability, the PCCD should therefore be removed as soon as

Conclusions

The results of this randomised clinical trial using healthy volunteers showed that patients with pelvic fractures, temporarily stabilised with a PCCD, will be at risk for developing pressure sores. The PCCDs exerted pressures on the skin that generally exceeds the tissue damaging threshold of 9.3 kPa. The amount of pressure is influenced by the type of PCCD, BMI, waist size, age and gender. PCCDs have been proven to be clinically effective [25]. There is room for improvement of the PCCD design

Conflict of interest statement

All authors state that no conflict of interest, neither financial nor personal, exists.

Acknowledgements

The Fonds NutsOhra is greatly acknowledged for their financial support of this study (grant nr. SNO-T-0701-117).

The data of the current study has been presented in the Best abstract session at the meeting “Chirurgendagen 2009” (May 15, 2009, Veldhoven, The Netherlands).

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