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.
|
