In studies 1-4 with 1338 patients and 1492 wounds, the following adverse reactions were reported:

Table 1 Adverse Reactions1-4


Adverse Reactions

Amiel et al1

Barnett et al2

Quinn et al3

Bruns et al4

Histoacryl®

Histoacryl®

Sutures

Histoacryl®

Sutures

Histoacryl®

Sutures

N, patients treated

1033

83

80

41

40

30

31

N, wounds treated

1150

100

100

41

40

30

31

Dehiscence**

Dehiscence-At Any Time

11 (1.1%)

0/62

0/40

3(8.1%)

2 (5.3%)

1 (3.0%)

1 (3.0%)

Wound Edge Separation Requiring Re-Treatment

1

0

0

2

1

0

0

Infection***

Suspected Infection

ND

0/62

  2/49

1/37 (2.7%)

1/38 (2.6%)

1/30 (3.0%)

ND

Acute Inflammation

Erythema

57 (5.5%)

ND

ND

1 (2.7%)

4 (11.5%)

ND

ND

Edema

5 (0.5%)

ND

ND

ND

ND

ND

ND

Drainage

20 (1.9%)

ND

ND

ND

ND

ND

ND

ND - No reported data
** Dehiscence was defined as: 1) separation of the incision that required medical attention and that almost exclusively was closed by secondary intention (i.e., Amiel et al1) or 2) a wound coming apart by the 7 days follow up visit (i.e., Barnett et al2) or a wound requiring delayed primary closure (Quinn et al3).  A prospective definition for dehiscence was not provided in Bruns et al4.
*** Infection was defined as: 1) a wound requiring antibiotic treatment (i.e., Amiel et al1 and Bruns et al4) or 2) an area of redness around the wound with or without discharge (i.e., Barnett et al2).  A prospective definition for wound infection was not provided in Quinn et al3.

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