Tissue Adhesive Abstracts
The results of four clinical studies performed with Histoacryl® are summarized below.
Amiel et al1
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.
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.
Barnett et al2
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.
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 all2
| Histoacryl Blue | Control Sutures | |
|---|---|---|
| Patient Accounting | ||
| N, patients enrolled | 83 | 80 |
| N, patients treated | 83 | 80 |
| Patients Completed | ||
| 1 week | 62 (74.6%) | 49 (61.2%) |
| 90 days | 46 (55.0%) | 44 (55.0%) |
| 12 months | 36 (43.0%) | 34 (43.0%) |
| Patient Demographics | ||
| Mean Age in months (std. dev.) | 69.5 (29) | 68.4 (30) |
| Males | 48 (57.8%) | 68 (85%) |
| Wound Characteristics | ||
| Length in cm – mean | 1.54 | 1.68 |
| Depth in cm – mean | ND | ND |
| Width in cm – mean | 0.34 | 0.28 |
| Wound Class: Clean | 100 (100%) | 100 (100%) |
| Incisions | 0 | 0 |
| Lacerations | 100 (100%) | 100 (100%) |
| Body Part | ||
| Face | 49 | 64 |
| Scalp | 35 | 29 |
| Other | 16 | 7 |
| Use of Anaesthesia | ||
| General | 0 | 0 |
| Local only | 0 | 80 (100%) |
| None | 83 (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).
Quinn et al3
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.
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 Quinn et al. 3
| 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.
Bruns et al4
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.
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[/av_cell][av_cell col_style='' av_uid='av-56vvum']22 (73%)[/av_cell][av_cell col_style='' av_uid='av-547a86']22 (71%)[/av_cell][/av_row] [av_row row_style='' av_uid='av-4wtnq6'][av_cell col_style='' av_uid='av-h5ezy']> 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
- 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)
- 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)
- 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)
- 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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