The impact of a muscle pump activator on incisional wound healing compared to standard stockings and compression devices in kidney and kidney-pancreas transplant recipients: A randomized controlled trial

Abstract

Introduction: We aimed to evaluate the impact of thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) vs. muscle pump activator (MPA) on incisional wound healing in kidney and simultaneous pancreas- kidney (SPK) transplant recipients.

Methods: We conducted a single-centre, randomized controlled trial in which 104 patients (kidney n=94; SPK n=10) were randomly assigned to wear TED + IPC (n= 52) or MPA (n=52) for the first six days following surgery. Patient demographics, postoperative outcomes, and incisional wound images were taken using a HIPAA-compliant application on postoperative days (POD) 3, 5, and 30, and assessed using the validated Southampton Wound Care Score.

Results: There were no demographic differences between the groups. The MPA group had a significant improvement in wound healing on POD 3 (p=0.04) that persisted until POD 5 (p=0.0003). At POD 30, both groups were similar in wound healing outcomes (p=0.51). Bayesian inferential analysis revealed that the use of TED + IPC following transplantation had inferior outcomes compared to the use of MPA with sequential moderate evidence. The rate of complex wound infections was significantly greater in the TED + IPC group compared to the MPA group (29% vs. 12%, respectively; p=0.03). Patients were more satisfied with the use of a MPA device than TED + IPC. No major complications were encountered in either group.

Conclusions: The use of a MPA device in the immediate postoperative period leads to a significant improvement in immediate and early wound healing, and decreased number of complex wound infections following kidney and SPK transplantation compared to standard TED + IPC therapy. Patients were more satisfied with the use of a MPA device than TED + IPC.

Fig. 1

CONSORT diagram for the trial (protocol #103618).

Fig. 2

Muscle pump activator (MPA) group patient post-kidney transplantation. Wound images taken at (a) 3; (b) 5; and (c) 30 postoperative days (POD) show serial improvement in wound scores.

Fig. 3

Thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) group patient post-kidney transplantation. Wound images taken at (a) 3; (b) 5; and (c) 30 postoperative days (POD) show interval improvement in wound scores.

Fig. 4

Muscle pump activator (MPA) group patient post-kidney-pancreas transplantation. Wound images taken at (a) 3; (b) 5; and (c) 30 postoperative days (POD) show serial improvement in wound scores.

Fig. 5

Thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) group patient post-kidney-pancreas transplantation. Wound images taken at (a) 3; (b) 5; and (c) 30 postoperative days (POD) show interval improvement in wound scores.

Fig. 6

At postoperative day (POD) 3, the thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) cohort had significantly higher wound score difference in comparison to the muscle pump activator (MPA) cohort (Pearson Chi-square 4.1; p=0.04; standard deviation [SD] ± 2.48 for TED + IPC group compared to MPA). Day 3 H0>H1 null hypothesis MPA leads to better wound scores compared to TED + IPC. Bayesian inferential analysis: strong evidence in favor of MPA.

Fig. 7

At postoperative day (POD) 5, the thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) cohort had significantly higher wound score (≥2) in comparison to the muscle pump activator (MPA) cohort (Pearson Chi-square 6.88; p=0.0003; standard deviation [SD] ± 1.81 for TED + IPC group compared to MPA). Day 5 H0>H1 null hypothesis MPA leads to better wound scores compared to TED + IPC. Bayesian inferential analysis: moderate evidence in favor of MPA.

Fig. 8

At postoperative day (POD) 30, the muscle pump activator (MPA) cohort had equivalent wound score in comparison to thrombo-embolic-deterrent + intermittent pneumatic compression (TED + IPC) cohort (Pearson Chi-square 6.20; p=0.51; standard deviation [SD] ± 1.84 for MPA compared to TED + IPC). Day 30 H0>H1 null hypothesis MPA leads to better wound scores compared to TED + IPC. Bayesian inferential analysis: equivalent evidence for either group.

Fig. 9

At postoperative day (POD) 3, the muscle pump activator (MPA) cohort had significantly lower wound score in comparison to thromboembolic-deterrent + intermittent pneumatic compression (TED + IPC) cohort (p=0.04). At POD 5, the MPA cohort had significantly lower wound score in comparison to TED + IPC cohort (p=0.0003). At POD 30, there was no significant difference between both groups (p=0.051). Null hypothesis MPA leads to better wound scores compared to TED + IPC. Bayesian inferential analysis: overall moderate in favor of MPA.