Preclinical animal study and human clinical trial data of co-electrospun poly(l-lactide-co-caprolactone) and fibrinogen mesh for anterior pelvic floor reconstruction

Figures & data

Table 1 Scoring criteria for microscopic evaluation

Category	Score
	0	1	2	3
Polymorphonuclear cells	0	1–5	6–10	>10
Mononuclear cells	0	1–5	6–10	>10
Collagen organization	Disorganized	Slightly organized	Moderately organized	Well organized
Vascularity	0	1–3	4–10	>10

Figure 1 Hardness and thickness of PLCL/Fg and PPM at the implant site during 24 weeks of study. (A) Hardness of the PLCL/Fg and PPM after implantation. (B) Increase in thickness of PLCL/Fg and PPM after implantation.

Abbreviations: Fg, fibrinogen; PLCL, poly(l-lactide-co-caprolactone); PPM, polypropylene mesh; wks, weeks.

Figure 2 (A) Representative cross-sections of PLCL/Fg and PPM samples stained with hematoxylin and eosin at 24 weeks time points (scale bar =500 μm, ×40). (B) Histological analysis of PLCL/Fg and PPM after implantation. (a) Average score for the number of polymorphonuclear cells. (b) Average score for the number of mononuclear cells. (c) Amount of vascularity. (d) Degree of collagen organization. *P<0.05.

Abbreviations: Fg, fibrinogen; MNs, mononuclear cells; PLCL, poly(l-lactide-co-caprolactone); PMNs, polymorphonuclear cells; PPM, polypropylene mesh; wks, weeks.

Figure 3 (A) Ball burst strength of PLCL/Fg after implantation for 24 weeks. (B) Representative cross-sections of PLCL/Fg and PPM samples stained with hematoxylin and eosin at 2, 4, and 12 weeks (scale bar =500 μm, ×40). The mesh structure of PLCL/Fg is indicated with hollow arrowheads, the regenerated muscle tissues are indicated with solid arrowhead, and the PPM filaments are indicated with stars.

Abbreviations: Fg, fibrinogen; PLCL, poly(l-lactide-co-caprolactone); PPM, polypropylene mesh; wks, weeks.

Table 2 Comparison of operation time and blood loss for PLCL/Fg and PPM groups

	Patients	Operation time (minutes)	Blood loss (mL)
PLCL/Fg	19	50.73±15.26	65.26±41.34
PPM	19	50.21±26.16	50.99±47.00
t-value		0.037	−0.25
P-value		0.103	0.8

Abbreviations: Fg, fibrinogen; PLCL, poly(l-lactide-co-caprolactone); PPM, polypropylene mesh.

Table 3 Comparison of preoperative and postoperative POP-Q of women undergoing repair with PLCL/Fg versus PPM

	PLCL/Fg group			PPM group
	Aa	C	D	Aa	C	D
Preoperation	1.20±1.84	0.52±3.41	−2.32±3.47	1.52±0.97	1.27±3.27	−3.05±2.24
1 month postoperation	−3	−5.82±1.05	−7.02±0.96	−3	−4.94±1.12	−5.63±2.77
t-value	9.106	8.690	6.767	19.078	7.500	4.397
P-value	0.000	0.000	0.000	0.000	0.000	0.000
Preoperation	1.20±1.84	0.52±3.41	−2.32±3.47	1.52±0.97	1.27±3.27	−3.05±2.24
3 months postoperation	−1.73±0.68	−4.38±1.39	−6±1.17	−3	−4.88±1.09	−5.47±2.66
t-value	5.951	5.504	5.435	19.078	7.590	4.246
P-value	0.000	0.000	0.000	0.000	0.000	0.001
Preoperation	1.20±1.84	0.52±3.41	−2.32±3.47	1.52±0.97	1.27±3.27	−3.05±2.24
6 months postoperation	−0.50±1.08	−3.79±1.52	−5.73±1.01	−3	−4.72±1.08	−5.38±2.62
t-value	3.088	4.712	4.905	19.078	7.911	4.255
P-value	0.007	0.000	0.000	0.000	0.000	0.001

Abbreviations: Aa, anterior vaginal wall 3 cm proximal to the hymen point; C, most distal edge of the cervix or vaginal cuff scar point; D, posterior fornix point; Fg, fibrinogen; PLCL, poly(l-lactide-co-caprolactone); POP-Q, pelvic organ prolapse quantification; PPM, polypropylene mesh.

Table 4 Comparison of 6-month postoperative POP-Q of women undergoing PLCL/Fg and PPM repair

	Aa	C	D
PLCL/Fg group	−0.50±1.08	−3.79±1.52	−5.73±1.01
PPM group	−3	−4.72±1.08	−5.38±2.62
t-value	4.693	1.415	−1.123
P-value	0.017	0.445	0.205

Abbreviations: Aa, anterior vaginal wall 3 cm proximal to the hymen point; C, most distal edge of the cervix or vaginal cuff scar point; D, posterior fornix point; Fg, fibrinogen; PLCL, poly(l-lactide-co-caprolactone); PPM, polypropylene mesh; POP-Q, pelvic organ prolapse quantification.