The results of four clinical studies performed with Histoacryl® are summarized below. 
For additional abstracts, click here.

1.   Amiel et al1

A.   Study Design

The study was an open-label retrospective trial designed to evaluate the safety and effectiveness of Histoacryl® Blue in approximating surgical incisions at three Israeli centers. 

The study population included pediatric patients undergoing elective surgical incisions (i.e., orchidopexy, inguinal hernia, umbilical hernia or hydrocele repair).  All incisions were 2 and 5 cm in length and closure was achieved with standard surgical techniques by attending physicians.  Final cutaneous closure was performed with Histoacryl®. 

Patients were discharged after 4-6 hours of observation.  Follow-up visits were 7 days and 4 to 8 weeks (if needed) after surgery.  A 12-item questionnaire was completed during a telephone interview with a family member within 6 months after treatment.

B.   Study Results

Patient Accounting and Demographics

A summary of patient accounting and demographics as well as wound characteristics are presented in Table 2.

Table 2: Summary of Patient Accounting, Demographics
and Wound Characteristics Reported by Amiel et. al1

Accounting

No. of pts (%)

Patient records reviewed

1098

Patients treated with Histoacryl

1033 (100%)

Wounds treated with Histoacryl

1150

Patients completing 7 day follow-up

905 (87.6%)

Patients attending 4 week follow-up

401 (38.8%)

Surgical Procedure

N (%)

Right inguinal hernia repair

407 (37%)

Left inguinal hernia repair

199 (18%)

Bilateral inguinal hernia repair

119 (11%)

Umbilical hernia repair

43 (4%)

Hydrocele repair

167 (15%)

Orchidopexy

163 (15%)

Patient Age

1 mo – 16 yrs

Wound Characteristics

 

  Length

2 - 5

  Depth

ND

  Width

ND

  Class

ND

  Incisions

1050

  Lacerations

0

Local Anesthetic use

 

  Patients using local anesthetic

1033 (100%)

Study Outcomes

The adverse reactions observed in patients are described in Table 1.  1022/1033 (98.9%) of the patients treated with Histoacryl® achieved wound closure without dehiscence or wound edge separation requiring re-treatment.

2.   Barnett et al.2

A.   Study Design

The study was a prospective, randomized trial designed to compare the safety and effectiveness of Histoacryl® Blue and sutures in closing simple pediatric lacerations in an emergency room setting at three facilities in Australia and New Zealand. 

Patients between the ages of 4 -12 years were enrolled if they had a clean laceration on any part of the body that was less than 5 cm in length.  Patients were excluded if: the wound occurred on the eyelid, mucous membrane or a joint margins (i.e. under any added tension) or if the wound required debridement or plastic surgery.

Patients were assessed after wound closure and at 1 week, 3 and 12 months after treatment. 

B.   Study Results

Patient Accounting and Demographics

A summary of patient accounting and demographics as well as wound characteristics are presented in Table 3.

Table 3: Patient Accounting, Baseline Demographics
and Wound Characteristics Reported in Barnett et al2

Histoacryl Blue

Control
Sutures

Patient Accounting

N, patients enrolled

83

80

N, patients treated

83

80

Patients completed:
1 week
90 days
12 months


62 (74.6%)
46 (55.0%)
36 (43.0%)


49 (61.2%)
44 (55.0%)
34 (43.0%)

Patient Demographics

Mean Age in months  (std. dev.)
Males                                       

69.5 (29)
48 (57.8%)

68.4 (30)
68 (85%)

Wound Characteristics

Length in cm - mean
Depth in cm - mean
Width in cm - mean
Wound Class:  Clean
Incisions
Lacerations
Body Part
     Face
     Scalp
     Other

1.54
ND
0.34
100 (100%)
0
100 (100%)

49
35
16

1.68
ND
0.28
100 (100%)
0
100 (100%)

64
29
7

Use of Anaesthesia

General
Local only
None

0
0
83 (100%)

0
80 (100%)
0

Study Outcomes

The adverse reactions observed patients are described in Table 1.  Closure of all 200 (100%) wounds was achieved in both treatment groups without dehiscence. (i.e., a wound that came apart by the 7 day follow up visit).

3. Quinn et al3

A.   Study Design

This study was a prospective, randomized controlled trial comparing closure of pediatric facial lacerations with Histoacryl® Blue and sutures in a single Canadian Emergency room facility. 

Patients, under the age of 18, with clean facial lacerations less than 4 cm in length and 0.5 cm in width were eligible for enrollment.  Patients with wounds requiring deep layer closure, caused by animal bites, lacerations on hair-bearing surface, crossing mucocutaneous junctions or heavily soiled and requiring debridement were excluded from enrollment. 

Patients were evaluated immediately after treatment as well as 5 days and 3 months after wound approximation. 

B.   Study Results

Patient Accounting and Demographics

A summary of patient accounting and demographics as well as wound characteristics are presented in Table 4.

Table 4: Summary of Patient Accounting, Baseline Demographics
and Wound Characteristics Reported by Quinn3 et al.

Histoacryl Blue

Control Sutures

Patient Accounting

 

 

N, patients enrolled

41

40

N, patients treated

37

38

Patients completed: 90 days

33 (89.1%) 

36 (94.7%) 

Patient Demographics

Age (years)

0.7-16

0.5-15

Mean (years)

4.7

4.5

Sex (Male)                                 

58%

42%

Wound Characteristics

Length in cm - mean

1.53

1.52

Depth

ND

ND

Width

ND

ND

Wound Class

ND

ND

Incisions

0

0

Lacerations-facial

37 (100%)

38 (100%)

Use of Anaesthesia

General

0

0

Local only

0

38 (100%)

None

37(100%)

0

Study Outcomes

The adverse reactions observed in patients are described in Table 1.  Wound closure without dehiscence was achieved in 34/37 (91.9%) of the Histoacryl and 36/38 (94.7%) of the suture-treated patients.

4.   Bruns et al4

A.   Study Design

This study was a prospective, randomized trial comparing closure of pediatric lacerations with Histoacryl Blue and sutures at three Emergency rooms within the U.S.

Patients between the ages of 1 – 18 years old with lacerations less than 5 cm were enrolled.  Wounds requiring the use of subcutaneous sutures were enrolled in this study.  Patients with lacerations in areas of high skin mobility or tension (e.g., joints, hands, feet, eyelids, ears, nose, mouth or perineum) were excluded from the study as were lacerations caused by dog bites or extending to the muscle or bone.   

Patients were evaluated after wound closure and at 1 week and 2 months after treatment.  

B.   Study Results

Patient Accounting and Demographics

A summary of patient accounting and demographics as well as wound characteristics are presented in Table 5 .

Table 5: Summary of Patient Accounting, Baseline Demographics
and Wound Characteristics Reported by Bruns et al4

 

Histoacryl

Sutures


Patient Accounting

 

 

N, patients treated

30

31

N, wounds treated

30

31

Attending 2 month visit

30

25

Baseline Demographics

Median Age

4 years

3 years

Gender (G: male)

24 (80)

25 (80)

Race

White

14 (47)

19 (61)

Black

16 (53)

12 (39)

Wound Characteristics

Length in cm - median    

1.5

1.5

Depth, (mm)

     <5mm

22 (73%)

22 (71%)

     >5mm

8 (27%)

9 (29%)

Width

ND

ND

Wound Class

ND

ND

Incisions

0

0

Lacerations (Facial)

37 (100%)

38 (100%)

Local Anesthetic used

Patients treated with anesthetic

13/30 (43%)

31/31 (100%)

Study Outcomes

The adverse reactions observed in patients after surgery are described in Table 1.  Wound closure without dehiscence was achieved in 29/30 (96.7%) of the Histoacryl and 30/31 (96.8%) of the suture-treated patients.

References 

  1. Amiel GE, Sukhotnik I, Kawar B, and Siplovich L, “Use of N-Butyl-2-cyanoacrylate in Elective Surgical Incisions- Longterm Outcomes,” J Am Coll Surg, Vol 189, 21-25 (1999)
  1. Barnett P, Jarman FC, Goodge J, Silk G, and Aickin R, “Randomized trial of Histoacryl Blue tissue adhesive glue versus suturing in the repair of pediatric lacerations,” J. Paediatr. Child Health 34, 548-550 (1998)
  1. Quinn JV, Drezwiecki A, Li MM, Stiell IG, Sutcliffe, Elmsie TJ, and Wood WE, “A Randomized, Controlled Trial Comparing Tissue Adhesive With Suturing in the Repair of Pediatric Facial Lacerations,” Annals of Emergency Medicine, 22 (7): 1130-1135  (1993)
  1. Bruns TB, Simon HK, McLario DJ, Sullivan KM, Wood RJ, and Anand KJS, “Laceration Repair Using a Tissue Adhesive in a Children’s Emergency Department,”  Pediatrics, 98, 673-675  (1996)

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