. 2015 Feb;40(2):141–149. doi: 10.1177/1753193414528843

Table 2.

AEs or complications occurring with fasciectomy from the European structured review and in the CCH clinical trials.

Fasciectomy surgery AE or complication			CCH treatment (N = 1082)
Surgery type	All surgery types, median (%)	Individual study estimates (%)	AE^*	%
Complex regional pain syndrome
Limited	4.5	18.5¹; 12.8²; 12.1²; 10.2³; 10.0⁴; 9.3⁵; 7.0⁶; 6.5⁵; 4.5⁷; 3.4⁸; 3.0⁹; 2.5¹⁰; 2.4¹¹; 1.5¹²; 1.3¹³	Complex regional pain syndrome	0.1
Dermofasciectomy		2.6¹⁰
Not specified		2.3¹⁴
Pain
Limited	20.4	48¹⁵; 20.4⁵; 20⁶; 3¹⁶; 2.4¹²;	Pain	3.4
Total		82.5¹⁷ and 85¹⁷
Arterial injury
Limited	5.5	9.7¹; 1.9^7,18; 1.0³; 0.8¹¹	NR^†
Not specified		16.5¹⁹ and 12¹⁹; 9.0²⁰ and 2.0²⁰
Haematoma
Limited	2.0	25²¹ and 5²¹; 5.5¹²; 4.0⁴; 2.9¹; 2.0¹¹; 1.9⁵; 1.22^22,23; 1.0⁴; 0.7⁶; 0^3,5,9,16	Contusion	54.5
Dermofasciectomy		14.9²⁴	Ecchymosis	17.9
			Haematoma	5.2
Total		7.7²⁵; 1.9¹⁷ and 0¹⁷	Haemorrhage	0.1
Neurapraxia
Limited	9.4	46⁶; 25¹⁰; 22.8²³; 5.5⁵; 3¹⁵; 1.0¹; 0.9²⁶; 0.4¹¹	Paraesthesia	2.2
Dermofasciectomy		51.3¹⁰ and 38.5¹⁰; 2.5¹¹; 0²⁴	Hypoaesthesia	1.7
Total		9.4²⁵ and 1.5²⁵	Hyperaesthesia	0.3
Not specified		46²⁷ and 26²⁷; 45.7¹⁹	Sensory disturbance	0.2
			Peripheral neuropathy	0.1
			Nerve compression	0
Nerve injury
Limited	3.8	13¹⁶; 7.8¹; 7.7⁷; 6.4² and 3.0²; 3.9¹³; 3.7²²; 3.2²⁴; 2.9¹⁸; 2.0^3,11; 1.9⁵; 1.8²³; 1.6¹²; 1.0¹²; 0.4⁴; 0⁸	Nerve injury	0
Dermofasciectomy		>50¹⁴ and 41.5¹⁴
Total		12.5²⁵; 9.4²⁵, 6.2²⁵, 4.6²⁵, 3.5²⁵ and 1.5²⁵; 9.6²⁶ and 4.2¹⁷
Skin injury
Limited	2.8	25.9⁸; 6.9⁷; 5.0¹⁸; 4²¹ and 3²¹; 2.8¹⁵; 2.6^13,22; 2.4¹¹ and 1.2¹¹; 1.0^3,10; 0.9^6,15; 0.4³; 0^5,6,9,16	Skin laceration	11.1
Dermofasciectomy		25.3²⁴, 8.9²⁴ and 7.4²⁴; 22.9²⁸ and 14.3²⁸; 12.7²⁶ and 1.3²⁶; 0¹⁰	Blister	2.3
Total		12.5¹⁷ and 7.7¹⁷; 1.5²⁵	Skin discoloration	0.8
Not specified		14¹⁴	Wound	0.6
			Skin disorder	0.3
			Skin haemorrhage	0.3
			Skin tightness	0.3
			Skin exfoliation	0.2
			Skin lesion	0.2
			Skin necrosis	0.1
			Wound dehiscence	0.1
Infection
Limited	4.5	9.6¹¹; 7.4¹²; 7.0¹⁸; 5.0¹⁰; 4.0¹⁶; 3.6^7,29; 3.2¹⁶; 0.8²⁴; 1.3⁴; 1.0¹; 0^3,9	Infection	0
Dermofasciectomy		5.0²²
Not specified		24.7¹⁹ and 20¹⁹
Tendon injury
Limited	0.1	0.2²²; 0²³	Tendon rupture	0.3
Other
Other^†	NR	NR	Oedema peripheral	77.4
			Injection site pain	40.6
			Pain in extremity	36.2
			Injection site haemorrhage	34.1
			Tenderness	28.7
			Injection site swelling	24.1
			Pruritus	12.6
			Lymphadenopathy	11.1
			Blood blister	9.0
			Axillary pain	6.7
			Injection site pruritus	5.3
			Injection site vesicles	4.4
			Erythema	4.0
			Lymph node pain	3.7
			Arthralgia	3.6
			Swelling	3.0
			Joint swelling	2.9
			Oedema	2.4

Note: Multiple values for the same reference may be due to: (1) reporting on different procedures; (2) reporting on two different patient groups; and/or (3) different outcomes reported under the same general heading in an article.

Events that appear in italics are treatment-related AEs that ‘mapped’ to terms presented in the European structured review and that occurred in the treated extremity at a frequency of ≥2%.

Treatment-related AEs that occurred in the treated extremity of CCH-treated subjects at a frequency of ≥2% and that were not ‘mapped’ to specific events or complications in the European structured review.

^†

None reported – skin laceration, wound are grouped under skin disorders.

(Sennwald, 1990) n = 103; ²(Citron and Nunez, 2005) n = 79; ³(Tripoli and Merle, 2008) n = 108; ⁴(Rodrigo et al., 1976) n = 153; ⁵(Foucher et al., 1995) n = 54; ⁶(Foucher et al., 1992) n = 107; ⁷(Coert et al., 2006) n = 261; ⁸(Norotte et al., 1988) n = 58; ⁹(Foucher et al., 1985) n = 139; ¹⁰(Ullah et al., 2009) n = 79; ¹¹(Bulstrode et al., 2005) n = 253; ¹²(Makela et al., 1991) n = 127; ¹³(Vigroux and Valentin, 1992) n = 56; ¹⁴(Kjeldal and Nygaard, 1988) n = 55; ¹⁵(Razemon, 1982) n = 107; ¹⁶(Macnicol, 1984) n = 103; ¹⁷(Ebskov et al., 1997) n = 76; ¹⁸(Denkler, 2005) n = 60; ¹⁹(Dias and Braybrooke, 2006) n = 1177; ²⁰(Messore et al., 1998) n = 443; ²¹(Gonzalez et al., 1998) n = 583; ²²(Loos et al., 2007) n = 2919; ²³(van Rijssen et al., 2006) n = 57; ²⁴(Hall et al., 1997) n = 67; ²⁵(Hogemann et al., 2009) n = 61; ²⁶(Roy et al., 2006) n = 79; ²⁷(Constantinou and Deutinger, 1996) n = 144; ²⁸(Tonkin et al., 1984) n = 163; ²⁹(Clibbon and Logan, 2001) n = 56

AE: adverse event; CCH: collagenase Clostridium histolyticum; NR: not reported in the literature.