Table 1.

Evidence for available skin substitutes used to treat chronic wounds.

	Class	Type of wound	Number of participants (n)	Comparison	Healed (%)	Time to closure (days)	FDA status	Effective-ness data
dHAM (100–102)	I	DFU	29	SOC*	33 vs. 0 at 6 weeks		HCT/P	+
		DFU	13	SOC*		29.5
vCPM (103–106)	I	VLU	21	SOC*	53 vs. 0 at 10.9 weeks		HCT/P	+
		DFU	26	SOC*	65.4 vs. 0 at 12 weeks	34
		DFU	97	SOC*	62 vs. 21 at 12 weeks	42
		DFU	62	DSS	48.4 vs. 38.7 at 8 weeks
dHACM (102, 107–111)	I	DFU	60	BLCC	85 vs. 35 (BLCC) vs. 30 (SOC*) at 4 weeks	13	HCT/P	+
				SOC*
		DFU	100	BLCC	97 vs. 73 (BLCC) vs. 51 (SOC*)	23.6
				SOC*
		DFU	110	SOC*	70 vs. 50 at 12 weeks
		VLU	109	SOC*	60 vs. 35 at 12 weeks
DermACELL® ADM (112)	II	DFU	168	GraftJacket® SOC*	65 vs. 41.1 (SOC*) at 12 weeks (No difference compared to Graft-jacket)	63	HCT/P	+
GraftJacket® ADM (112)	II	DFU	168	DermACELL® SOC*	No difference compared to DermA-CELL® or SOC*		HCT/P	+
SIS (54, 55, 113–117)	II	VLU	120	SOC*	55 vs. 34 at 12 weeks		HCT/P	+
		Mixed VLU and arterial	54	Hyaloskin®	82.6 vs. 46.2 at 16 weeks
		Mixed VLU and arterial	50	Petrolatum-Moistened Gauze	80 vs. 65 in 8 weeks
		DFU	55	DSS	73.7 vs. 47.1 (DSS) vs. 57.9 (SOC*) at 12 weeks
				SOC*
UBM (118)	II	DFU	56	DSS	No significant difference		510(k)	+
HR-ADM (49)	II	DFU	40	SOC*	65 vs. 5 at 6 weeks	28	HCT/P	+
DSS (119–122)	II	DFU	46	SOC*	71.4 vs. 14.3 at week 12		PMA	+
		VLU	18	SOC*	50 vs. 12.5 at 12 weeks
		VLU	366	SOC*	34 vs. 31 at week 12
CHSA (123)	III	DFU	23	DSS	63.6 vs. 33.3 at 12 weeks	62.3	HCT/P	+
BLCC (124–130)	III	DFU	72	SOC*	51.5 vs. 26.3 at 12 weeks	84	PMA	+
		DFU	208	SOC*	56 vs. 38 at 12 weeks	65
		DFU	17	SOC*	56 vs. 37 at 12 weeks
		Arterial	31	SOC*	62 vs. 0 and 8 weeks	49
		VLU	120	SOC*	47 vs. 19 in 6 months	181
DRT (112–114, 131–133)	III	DFU	307	SOC*	51 vs. 32 at 16 weeks	43	PMA	+

The table depicts RCT data for available skin substitutes that are currently used in the treatment of chronic wounds. *SOC is used to denote standard of care. DFU, diabetic foot ulcer; VLU, venous leg ulcer; dHAM, dehydrated human amniotic membrane; vCPM, cryopreserved placental membrane containing viable cells; dHACM, dehydrated amnion and chorion membrane; ADM, acellular dermal matrices; SIS, small intestine submucosa; UBM, urinary bladder matrix; HR-ADM, human reticular acellular dermal matrix; DSS, dermal skin substitutes; CHSA, cryopreserved human skin allograft; BLCC, bilayered cellular construct; DRT, dermal regenerative template; SOC, standard of care; HCT/P, human cells, tissues, and cellular and tissue-based products; 510(k), 510(k) premarket notification; PMA, premarket approval.