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Table 3 Summary of included primary clinical studies

From: Pelvic circumferential compression devices for prehospital management of suspected pelvic fractures: a rapid review and evidence summary for quality indicator evaluation

Author Year of publication Study Design Pertinent Objective(s) Number of patients/ participants Patients/participants and groups Device(s)/Intervention(s) Results summary LOE
Schweigkofler, et al. [35] 2019 Retrospective Cohort study To evaluate the effects of early (prehospital) application of a PCCD on transfusion requirements and mortality. 64 Trauma patients with Tile B (n = 31; 48.4%) and Tile C (n = 33; 51.6%) unstable pelvic fractures. A PCCD was applied prehospitally in 37 patients (58%); 27 (42%) received no prehospital pelvic binding. Unspecified PCCD There were higher ISS scores (29.7 vs 24.2) and lower probability of survival (RISC-II Prognosis 81% vs 89%) in patient who had a PCCD applied, however this was not statistically significant. There was also higher risk for massive transfusion (TASH-Scores 10% vs 6%) and average number of PRBC units transfused (10.5 vs 7.5) in patient with PCCD, again without statistical significance though. There was no statistically significance difference in mortality (20% vs 13.3% respectively). 3
Agri, et al. [36] 2017 Retrospective Cohort study To describe the correlation between pelvic binders and patient outcomes. 228 Adult (> 16 years) trauma patient with Tile A (n = 52; 22.8%), Tile B (n = 71; 31.1%) and Tile C (n = 105; 46.1%) pelvic fractures. Pelvic binders had been applied to in the field to 144 patients (63%) with comparable frequency among the three main fracture types (p = 0.61). Unspecified PCCD (and AAE) Tile C fractures were associated with higher transfusion requirements (p < 0.0001) and higher mortality (p < 0.001).
There was no statistically significant difference in injury severity between patient with PCCD and those without (ISS 26 vs 29; p = 0.99). Pelvic binders were not associated with differences in PRBC transfusion requirements (0 vs 2; p = 0.91) or mortality rates at 48 h (23% vs 18%; p = 0.5) or 30 days (25% vs 11%; p = 0.51) compared to the absence of pelvic binders. There were also no statistically significant differences in SBP, HR, SI, lactate level, SBD or need for AAE. No differences were detected in any of these variables even when selecting unstable fracture types (B1, B3 and C) only.
3
Hsu, et al. [37] 2017 Retrospective Cohort study To compare the effects of early pelvic binding (based on suspicion of pelvic injury) with late pelvic binding (after fracture confirmation by radiography) 204 Trauma patients with a loss of consciousness or GCS < 13, SBP < 90 mmHg, fall from ≥6 m; injury to multiple vital organs, and suspected pelvic injury. Pelvic binders had been applied to 56 (27.5%) patients after confirmation of pelvic fracture and 148 (72.5%) patients with suspected pelvic injury. SAM Pelvic Sling® II There were no statistically significant differences in hospital LOS, ICU LOS, RTS, ISS score; percentage of SBP < 90 mmHg, GCS, percentage of AIS ≤3, angiography for AAE or mortality. However, those patients who received early pelvic binding had significantly less blood transfusion requirements (2462 ml vs 4385 ml; p = 0.009). Furthermore, uni- and multivariant regression analysis to adjust for confounders revealed significantly reduced mortality rates associated with early binding (p = 0.030 and p = 0.039 respectively). 3
Fu, et al. [38] 2013 Retrospective Cohort study To evaluate the effects of PCCDs in patients with pelvic fractures who required transfer to trauma centres. 585 Patients with stable (n = 450; 76.9%) and unstable (n = 135; 23.1%) pelvic fractures who were transferred to a trauma centre within 24 h. Unspecified PCCD or sheet wrapping The patients with stable pelvic fracture who received pretransfer PCCDs (n = 62; 13.8%) required significantly fewer blood transfusions (120.2 ml vs 231.8 mL; p = 0.018), had shorter intensive care unit LOS (1.7 days vs 3.4 days; p = 0.029) and shorter hospital LOS (6.8 days vs 10.4 days; p = 0.018) compared with patients who did not receive the pretransfer PCCD. The patients with unstable pelvic fractures who received pretransfer PCCDs (n = 91; 67.4%) also required significantly fewer blood transfusions (398.4 ml vs 1954.5 ml; p < 0.001), shorter intensive care unit LOS (6.6 days vs 11.8 days; p = 0.024) and shorter hospital LOS (9.4 days vs 19.5 days; p = 0.006) compared with patients who did not receive the pretransfer PCCD. 3
Pizanis, et al. [39] 2013 Retrospective Cohort study To compare transfusion requirements of PRBC, LOS, mortality and incidence of lethal pelvic bleeding between patients which were treated by circumferential sheets, binders and c-clamps. 192 Trauma patients with fractures or disruptions of the pelvic ring. (The median age of patients treated with binders was significantly lower than in those treated with sheets of c-clamps.) One-hundred-and-thirty-three patients (69%) were treated with c-clamp, 31 (16%) with sheets and 28 (15%) with binders. Unspecified PCCDs, sheet wrapping and c-clamp There were no statistically significant differences in PRBC requirements (p = 0.26), LOS (p = 0.20) or mortality (p = 0.08). However, wrapping sheets were associated with a significantly higher incidence of lethal bleeding compared to PCCD and c-clamp (23% vs 4% vs 8%; p = 0.02). 3
Knops, et al. [32] 2011 Randomized controlled trial To quantify the pressure at the region of the greater trochanters and the sacrum, induced by PCCDs in healthy individuals. 80 Healthy individuals lying on a spine board and lying on a hospital bed. Pelvic Binder®, SAM-Sling® and T-POD® Whilst lying on a spine board, the maximum pressure on the skin at the area of the greater trochanter exceeded 9.3 kPa (tissue damage threshold) with all three devices. No correlations of maximum pressure with BMI, waist size, or age on a spine board at the area of the greater trochanter were observed, except with an increase in maximum pressure with age (p = 0.031) when using one of the devices (SAM-Sling®). Whilst lying on the hospital bed, considerable reductions in maximum pressure, were found with all devices, in most cases below 9.3 kPa. 1
Tan, at al [33]. 2010 Before-after study To measure the immediate biomechanical and hemodynamic effects of pelvic binding. 15 Patients with unstable pelvic fractures who presented to the emergency department and who did not receive prehospital pelvic binding. T-POD® Application of the PCCD reduced pubic symphyseal diastasis by 60% (range 24–92%, p = 0.01). Mean values of mean arterial pressures increased significantly from 64.7 to 81.2 mmHg (p = 0.04). Similarly, heart rates decreased significantly from 106 to 93 beats per minute (p = 0.04). 2
Croce, et al. [40] 2007 Retrospective Cohort study To compare the efficacy of pelvic binding to EPF. 186 Trauma patients with fractures or disruptions of the pelvic ring.
Ninety-three patients (50%) were treated with EPF and 93 (50%) had the T-POD applied.
T-POD® There were no differences in age or shock severity. Those patients who had a T-POD applied had significantly reduced 24-h (4.9 U vs 17.1 U; p < 0.0001) and 48-h transfusions (6.0 U vs 18.6 U; p < 0.0001). Compared to EPF, the T-POD also facilitated significantly decreased hospital LOS (16.5 days vs 24.4 days; p < 0.03). There was reduced mortality with the T-POD, however, this was not statistically significant (26% vs 37%; p = 0.11). 3
Ghaemmaghami, et al. [41] 2007 Retrospective Cohort study To assess the effectiveness of early application of a PCCD when compared to no device. 236 Patients with pelvic fractures and at least one of the following risk factors:
- unstable fracture
- age > 55 years
- hypotension
One-hundred-and-eighteen patients (50%) were treated with the PCCD and 118 (50%) did not receive any standardized pelvic binding other than occasional sheet wrapping.
Unspecified PCCD The two groups had similar fracture patterns, age, and injury severity. In the comparison of patients wo were treated with a PCCD with those who received no standardized pelvic binding, there were no significant differences in mortality (23% vs 23%; p = 0.92), need for AAE (11% vs 15%; p = 0.35), or 24-h transfusion (5.2 U vs 4.6 U; p = 0.64). 3
Krieg, et al. [34] 2005 Before-after study To assess the effectiveness of a PCCD in reducing and stabilizing pelvic ring fractures. 13 Adult patients (>  16 years) with partially stable or unstable pelvic fractures with external or internal rotation pattern. Unspecified PCCD In patients with external rotation, the PCCD significantly reduced the pelvic width by 9.9 ± 6.0%. In patient with internal rotation, there was no significant over-pressurization due to application of the PCCD. 2
  1. AAE Arterial Angio-Embolization; AIS Abbreviate Injury Score; BMI Body Mass Index; EPF External Pelvic Fixation; GCS Glasgow Coma Score; HR Heart Rate; ICU Intensive Care Unit; ISS Injury Severity Scale; LOE Level of Evidence; LOS Length of Stay; PCCD Pelvic Circumferential Compression Device; PRBC Packed Red Blood Cells; RISC Revised Injury Severity Classification; RTS Revised Trauma Score; SBD Standard Base Deficit; SBP Systolic Blood Pressure; SI Shock Index; TASH Trauma Associated Severe Haemorrhage