# Abstract

 

## Background Spinal fusion surgery is associated with significant blood loss, which may result in potential clinical complications, it is necessary to take safe and effective measures to reduce blood loss in surgery. We perform this study to assess the impact of three different hemostatic materials on perioperative blood loss. 

## Methods We performed a Randomized Controlled Trial research and recruited patients with lumbar disease into the study between November 2013 and March 2015. All the participants were randomly assigned to 3 groups using a simple equal probability randomization scheme: Group A (Stypro hemostatic sponge), Group B (Collagen hemostatic sponge) and Group C (gelatin sponge). We compared postoperative blood loss between these 3 groups. 

## Results In our study, drainage volume in the first 24 h of patients in Group A and B is significantly smaller, as well as total postoperative volumes of drainage (*p* \< 0.05) during their hospital stay. The drainage volumes in the second 24 h were similar in the 3 groups. We also found that the average drainage Hematocrit (HCT) reduced over time, the average HCT of drainage is 18.04% and 11.72% on the first day and on the second day respectively. 

## Conclusions Hemostatic collagen sponge demonstrated better hemostasis effects than gelatin sponge with lower volume of postoperative drainage volume and blood loss in posterior spinal fusion surgery. 

## Trial registration The trial registration number (TRN) of the study is [ISRCTN29254316](#) and date of registration is 25/10/2016. Our trial was registered retrospectively. # Results In this study, 92 patients who met the inclusion criteria were enrolled. Among these patients, 30 patients were assigned to group A, 30 patients were assigned to group B and 32 patients were assigned to group C. No significant difference in age, height, weight, BMI, surgical level, intraoperative blood loss, operative durations, the mean length of hospital stay and coagulation indices were identified between the 3 groups, as presented in Table [1](#). ::::table-wrap

::: caption
Demographic date
:::

Variable Group A Group B Group C

______________________________________________________________________

N 30 30 32
Age (year) 56.1 ± 12.9 55.6 ± 12.3 56.7 ± 13.4
Sex\
Males 12 13 13
Females 18 17 19
BMI (kg/cm2) 24.83 ± 3.6 24.93 ± 3.3 24.81 ± 3.4
Preoperative HGB (g/L) 123.2 ± 10.5 125.1 ± 9 126.4 ± 8.4
Surgical level 2.31 ± 0.09 2.76 ± 0.12 2.40 ± 0.10
Operative time (min) 118.0 ± 24 150.6 ± 47 135.6 ± 39
Blood loss (ml) 202.5 ± 25 292.7 ± 39 259.8 ± 37
Mean duration of hospital stay (days) 6.82 ± 1.2 6.89 ± 1.3 7.3 ± 1.3:::: The detailed information of drainage at various time points is presented in Table [2](#) and Fig. [2](#). Compared with patients in Group C, patients in Group A and B exhibited significantly smaller drainage volume in the first 24 h, as well as total postoperative volumes of drainage (*p* \< 0.05) during their hospital stay. The drainage volumes in the second 24 h were similar in the 3 groups and exhibited no significant differences. ::::table-wrap
::: caption
The information of postoperative drainage
:::

Variable Group A Group B Group C

______________________________________________________________________

Volume of Drainage in 24 h (ml)\* 187.9 ± 82 185.2 ± 68 230.8 ± 75
Volume of Drainage in the second 24 h (ml) 53.7 ± 3.8 63.3 ± 8.9 63.5 ± 14.2
Total volume of drainage (ml)\* 231.5 ± 18.1 248.5 ± 18.8 318.5 ± 26.7

\*Data between 3 groups has siginificant difference:::: <figure> <p><img src="" /></p> <figcaption>Comparison of postoperative drainage</figcaption> </figure> The HCT data of each drainage sample are presented in Table [3](#), from which we learned that on the first day, the average HCT of drainage is 18.04%, which is lower than that in whole blood CBC by a small extent. However, the average drainage HCT reduced over time. On the second day, when the drainage was removed, the average HCT dropped to 11.72%.We also found that the HCT of drainage at different stage were similar for patients in 3 groups. ::::table-wrap
::: caption
The Drainage blood of postoperative drainage
:::

Variable Group A Group B Group C

______________________________________________________________________

HCT of Drainage in 24 h (%) 18.04 ± 1.22 20.85 ± 1.16 21.06 ± 1.17
HCT of Drainage in the second 24 h (%) 11.72 ± 1.17 13.22 ± 1.23 12.53 ± 1.24
Drainage blood in 24 h (ml)\* 34.95 ± 5.05 39.37 ± 3.79 54.06 ± 5.56
Drainage blood in the second 24 h (ml) 4.85 ± 0.66 7.39 ± 1.07 7.79 ± 3.58
Total volume of drainage blood (ml)\* 39.62 ± 5.13 47.53 ± 6.08 61.84 ± 6.60

\*Data between 3 groups has siginificant difference:::: There were no perioperative complications, such as deep venous thrombosis (DVT)/pulmonary embolism (PE), postoperative hematomas/seromas, and postoperative infections, in the 3 groups.


Extracted trial result:
Outcome: Total drainage volume (continuous)
Intervention: Stypro hemostatic sponge
Comparator: Gelatin sponge
Intervention group size: 30
Intervention mean: 231.5
Intervention standard deviation: 18.1
Comparator group size: 30
Comparator mean: 318.5
Comparator standard deviation: 26.7