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Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial
R Schräder1, S Steinbacher, W Burger
1Division of Cardiology, University-Hospital, Frankfurt am Main, Germany.
Insights
Percutaneously applied collagen significantly reduces compression time and speeds up patient ambulation after femoral artery catheterization. This innovative approach also lowers the incidence of bleeding and hematomas compared to traditional pressure dressings.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Femoral artery access is common in diagnostic and interventional catheterization.
- Achieving hemostasis after femoral artery puncture can be time-consuming and associated with complications.
- Conventional pressure dressings require prolonged compression and bedrest.
Purpose of the Study:
- To evaluate the efficacy and safety of percutaneously applied collagen versus conventional pressure dressing for femoral artery sealing.
- To compare compression time, bleeding incidence, time to ambulation, and hematoma formation between the two methods.
Main Methods:
- Randomized controlled trial involving 100 patients undergoing femoral artery catheterization.
- Patients were assigned to receive either percutaneously applied collagen (n=50) or conventional pressure dressing (n=50).
- Key outcomes measured included compression time, bleeding, time to ambulation, and hematoma size.
Main Results:
- Percutaneous collagen group showed significantly reduced average compression time (4.3 min vs. 42.3 min) and time to ambulation (6.4 hr vs. 21.6 hr).
- Lower incidence of bleeding (0% vs. 12%) and large hematomas (>6 cm) (8% vs. 22%) observed in the collagen group.
- No blood transfusions, surgical interventions, or loss of ankle pulses were required in either group.
Conclusions:
- Percutaneously applied collagen is a safe and effective alternative for femoral artery sealing post-catheterization.
- Collagen significantly shortens compression time, reduces bedrest duration, and lowers complication rates.
- This method facilitates earlier patient ambulation without compromising safety.
Abstract:
One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.