A prospective randomized controlled trial on the use of body exhaust suit in primary total knee arthroplasty

Abstract

Introduction This study aims to compare the rate of intra-operative contamination in primary total knee replacement with the body exhaust suit and conventional gowns. Materials and Methods In this randomized study, 64 TKAs of 32 patients were recruited. A pre-operation screen was needed to assess the feasibility and necessity to conduct bilateral TKA operation on schedule . Those eligible to the inclusion criteria were taken in to the study after being informed the consent. The study was divided into two groups randomly. Conventional gowns group (n=31), the whole surgical team wore conventional gowns during the TKA surgery; Space suit group (n=31), the whole surgical team wore space suits during the TKA surgery. The bilateral arthroplasty was performed by the two groups in sequence and the sequence was randomly generated from a computer. The surgeons in both team didn’t know the sequence of another team. The space suit included disposable hoods and masks. The scrub nurse should wear space suits during the whole operation. Double gloving was a necessary procedure for all surgeons. All operations were performed in routine technique aims to restore the neutral mechanical lower limb alignment. Microbiological assay was the crucial component of the whole process. Wound swabs for bacteria culture were collected immediately after skin incision. Subcutaneous layer after skin incision (skin pre-op). Proximal tibia bone cut surface before implantation (tibia). Distal femoral bone cut surface before implantation (femur). Anterior femoral condyle (prosthesis) before arthrotomy closure (implant). Subcutaneous layer before skin closure (skin post-op). Patient specimens were processed immediately after their arrival at the laboratory. Cultivation of tissue samples was performed essentially as described in previous study. In order to guarantee the recovery of the patients and the whole study smoothly conducted, lower limb radiography is needed to assess the restore of the mechanical axis. Result Among the 31 patients recruited, there were 21 females (67%) and 10 males (23%). The body mass index (BMI) was 27.43±4.97 kg/m2. 86.67% were over-weight (BMI > 23 kg/m2) and 38.71% were obese (BMI > 30 kg/m2). The operation time of the whole surgery was 175.61±46.71min. Lower limb alignment with space suit was 15.03±8.44° varus. Lower limb alignment with conventional gown was 14.82±6.76° varus. The operation time with space suit was 85.39±19.48 min; the operation time with conventional gown was 86.10±31.45 min. The number of times the surgeon changed gloves were 0.77±1.45 in space suit group and 1.71±1.51 in conventional gown group. The number of times the surgeon touched helmet was 0.06±0.25. There was no significant difference in the operation time (P > 0.05) and varus angulation (P > 0.05) between the two groups. However, the glove changing times with conventional gown was significant increased when compared with the space suit group (P < 0.05). Various strains of bacteria were tested in the culture and the bacterial culture results of the specimens were negative in the two groups. Conclusion Our study demonstrates that there is no benefit in the use of body exhaust suit in decreasing the rate of wound contamination when compared with the conventional gown. The suit is not a must to prevent PJI. However, although there's still a lot to improve, the modern positive-pressure surgical helmet body exhaust systems can be considered as a protection device to protect the blood, soft tissue, bone crumbles from splashing on the performers’ skin. Considering the large amount of splashes and sprays in the orthopedic procedures, the body exhaust systems should be mandatory during the procedure of TKA.