Fixation of Light Weight Polypropylene Mesh with n-Butyl-2-cyanocrylate in Pelvic Floor Surgery: Experimental Design Approach in Sheep for Effectiveness Evaluation
Table 3
Data showing clinical and macroscopic scores in pilot study groups and main study groups (bold). Note that mean daily clinical score is based on 21 days for pilot studies and on 3 and 6 months in the definitive study.
Experimental group
Mean daily clinical score (up to 21 points)
Macroscopic score
Fibrous reaction
Abscesses
Vaginal exposure
Intestinal exposure
Mesh folding
Vaginal stricture
PP-1-Hist anterior (5 × 5 cm)
0.42
2.33
1
2/3
0/3
2/3
0/3
PP-1-Hist posterior (5 × 5 cm)
0.60
2.67
1b
2/3
1/3
1/3
0/3
PP-1-PP anterior (3 × 4 cm)
1.00
2
0
1/1
0/1
1/1
0/1
PP-1-PP posterior (4 × 4 cm)
0.77
3
1b
1/1
0/1
1/1
0/1
Omy-TF-PP posterior (2-3 × 3-3 cm)
0.63
1.5
0
0/2
0/2
0/2
0/2
PP-2-PP anterior (2 × 2 cm)
0.85
2
0
0/1
0/1
0/1
0/1
PP-2-PP posterior (3 × 3 cm)
0.46
3
3
1/1
0/1
1/1
0/1
PP-1-Hist-3m (3–3.5 × 3.2–3.5)
0.42
1.75
0/4
0/4
0/4
0/4
0/4
PP-1-Hist-6m (3–3.5 × 3.2–3.5)
0.28
1
0/4
0/4
0/4
1/4
0/4
Fold in one of the corners of the mesh. It does not represent the complete folding of the mesh. bAbscesses detected by histology of approximately 5 mm of diameter but considered as macroscopic finding.