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Snyder DL, Sullivan N, Schoelles KM. Skin Substitutes for Treating Chronic Wounds [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Dec 18.

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Skin Substitutes for Treating Chronic Wounds

Skin Substitutes for Treating Chronic Wounds [Internet].

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Table 13Results for complete wound healing

StudyWound TypeSkin SubstituteComparisonNumber of Patients in StudyDifference in Rate of Wounds Healed (Skin Substitute – Comparator)p-ValueaRelative Risk for Complete Wound Healing (95% CI) for Skin Substitute vs. Comparatora
DiDomenico et al. 201164DFUApligrafTheraSkin28Healed at 12 weeks
41% - 67% = -26%
NS (p=0.21)0.66 (0.33 to 1.30)
Landsman et al. 200854DFUOasis Wound MatrixDermagraft26Healed at 12 weeks
77% - 85% = -8%
NS (p=0.62)0.91 (0.62 to 1.33)
Reyzelman et al. 200966DFUGraftjacket acellular matrixMoist wound therapy with alginates, foams, hydrocolloids, or hydrogels85Healed at 12 weeks
70% - 46% = 24%
0.031.51 (1.02 to 2.22)
Brigido 200659DFUGraftjacket acellular matrixWeekly debridement, Curasol wound hydrogel and gauze dressing28Healed at 12 weeks
57% - 7% = 50%
0.0018.00 (1.15 to 55.80)
Niezgoda et al. 200570DFUOasis Wound MatrixRegranex Gel (contains platelet-derived growth factor)98Healed at 12 weeks
49% - 28% = 21%
NS (p=0.06)1.75 (0.94 to 3.26)
Edmonds 200953DFUApligrafNonadherent dressing72Healed at 12 weeks
52% - 26% = 26%
0.031.96 (1.05 to 3.66)
Marston et al. 200356DFUDermagraftSaline-moistened gauze245Healed at 12 weeks
30% - 18% = 12%
0.031.64 (1.03 to 2.62)
Naughton et al. 199762DFUDermagraftSaline-moistened gauze109Healed at 12 weeks
39% - 32% = 7%
NS (p=0.28)1.21 (0.86 to 1.72)
Gentzkow et al. 199665DFUDermagraftSaline-moistened gauze50Healed at 12 weeksb
30% - 8% = 22%
0.041.93 (0.49 to 7.59)
Veves et al. 200167DFUGraftskinSaline-moistened gauze208Healed at 12 weeks
56% - 38% = 18%
0.011.50 (1.11 to 2.04)
Uccioli et al. 201168DFUHyalograft 3D autograft/Lasers SkinNonadherent paraffin gauze160Healed at 12 weeks
24% - 21% = 3%
NS (p=0.64)1.15 (0.64 to 2.04)
Caravaggi et al. 200358DFUHyalograft 3D autograft/LaserSkinNonadherent paraffin gauze79Healed at 11 weeks
65% - 50% = 15%
NS (p=0.17)1.30 (0.88 to 1.93)
Falanga et al. 199863Leg, VenousApligraf and elastic compression bandageCompression therapy with a Unna boot and elastic compression bandage275Healed at 12 weeksc
53% - 22% = 31%
<0.001a2.38 (1.67 to 3.39)
Krishnamoorthy et al. 200355Leg, VenousDermagraft plus multilayered compression bandage therapy (Profore™)Multilayered compression therapy52Healed at 12 weeks
28% - 15% = 13%c
NS (p=0.30)c1.83 (0.47 to 7.21)c
Romanelli et al. 201057Leg, MixedOasis Wound MatrixPetrolatum-impregnated gauze48Healed at 8 weeksd
80% - 65% = 15%
NS (p=0.25)d1.23 (0.86 to 1.75)
Romanelli et al. 200760Leg, MixedOasis Wound MatrixHyaloskin (contains hyaluronan)54Healed at 16 weeks
83% - 46% = 37%
0.0011.91 (1.16to 3.14)
Mostow et al. 200569Leg, VenousOasis Wound Matrix with compressionCompression alone120Healed at 12 weeks
55% - 34% = 21%
0.0221.59 (1.04 to 2.42)
Kelechi et al. 201161Leg, VenousTalymed poly-N-acetyl glucosamine (pGlcNAc) with compressionNonadherent absorptive primary dressing with compression82Healed at 20 weekse
66% - 45% = 21%
NS (p=0.10)1.47 (0.88 to 2.46)e

DFU: Diabetic foot ulcer

HYAFF: Benzyl esters of hyaluronic acid

Leg: Vascular leg ulcer

NS: Not Statistically Significant

a

Calculated by ECRI Institute; p values are for Risk Difference

b

Calculated for all three active groups combined vs. control. A dose-response was noted with more frequent application of Dermagraft associated with higher percentage of patients with complete wound healing.

c

Complete healing at 12 weeks calculated from Figure 1 C in Brigido (2006) and from Table 2 and Figure 5 in Falanga (1998)

d

The publication states that the p-value for this comparison was “P<0.05”; however we calculate a risk difference of 0.15 (-0.10 to 0.40), p=0.25, a nonsignificant result. The authors state that they used “analysis of variance for multiple comparisons,” but no variables by which the data might have been adjusted are discussed.

e

All 3 Talymed groups combined vs. placebo; for groups receiving Talymed every other week to every third week vs. control, the difference was significant at the p=0.016 level, and the relative risk was 1.69 (1.01 to 2.83).

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