HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

It is Our Intent to Conduct a Prospective Randomized Controlled Trial Examining the Use of Histoacryl© in the Closure of Surgical Incisions in Comparison to Subcuticular Suture and to Dermabond©.

The use of tissue adhesives for the closure of surgical incisions is becoming increasingly common. Several publications exist purporting the equivalence of tissue adhesive to suture with regard to dehiscence, infection, and cosmesis. Two of the most frequently used adhesives are Histoacryl© and Dermabond©. Despite their popularity, only one study exists comparing the two. In this non-English study only small wounds in an exclusively pediatric population were studied (12). Operative time, cost, and objective measures of scar size were not examined. In the present study we aim to evaluate the relatively large surgical incisions resulting from breast reduction, mastopexy, panniculectomy, and abdominoplasty closed with either Histoacryl©, Dermabond©, or subcuticular suture. The primary aim is to investigate differences in time to wound closure. Secondary aims are to compare the three approaches with respect to cost, dehiscence, infection, scar size, and cosmesis.

Study Overview

• Status: Completed
• Conditions: Surgical Incisions
• Intervention / Treatment: Procedure: adhesive to suture

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

1) and 2): Reduction Mammoplasty or mastopexy patients: Patients who present to the plastic surgery clinic and are scheduled for breast procedures will be recruited and consented by a clinical studies co-ordinator. This will include patients undergoing a standard Wise pattern reduction mammoplasty (reduction and lift) or a standard Wise pattern mastopexy (lift only). See exclusion criteria below.

1) and 2): Abdominoplasty or panniculectomy patients: Patients who present to the plastic surgery clinic and are scheduled for abdominal procedures will be recruited and consented by a clinical studies coordinator. See exclusion criteria below.

Description

Inclusion Criteria:

• Age: Younger than 21
• Gender: Females only. Given the nature of the procedures, as well as our clinical experience, we cannot anticipate recruiting enough male patients to be able to evaluate them as a subgroup. Since there may be differences in distributions of measures, to keep the groups more homogeneous we plan to recruit only females from the outset. Having either:

• Reduction Mammoplasty or mastopexy patients:

  • Patients who present to the plastic surgery clinic and are scheduled for breast procedures will be recruited and consented by a clinical studies co-ordinator.
  • This will include patients undergoing a standard Wise pattern reduction mammoplasty (reduction and lift) or a standard Wise pattern mastopexy (lift only). See exclusion criteria below.

• Abdominoplasty or panniculectomy patients:

  • Patients who present to the plastic surgery clinic and are scheduled for abdominal procedures will be recruited and consented by a clinical studies coordinator. See exclusion criteria below.

Exclusion Criteria:

• Though women of childbearing age will be allowed to participate in this study, no pregnant patients will be enrolled.

• Patients with any factors that may have an adverse effect on wound healing:

  • previous hypertrophic scars or keloid
  • known vitamin C deficiency
  • known zinc deficiency
  • smoking
  • steroid use
  • known connective tissue disorder
  • hypoalbuminemia
  • any factor not listed that the attending consultant seeing the patient feels would adversely effect wound healing.
• Patients who have a known sensitivity to adhesives

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1-abdominal; half abdominal surgeries (20 patients out of 40)	Procedure: adhesive to suture; surgical closure; Other Names: Dermabond, Histoacryl, or sutures --patients could be randomized to.
2-breast; half breast surgeries (20 out of 40)	Procedure: adhesive to suture; surgical closure; Other Names: Dermabond, Histoacryl, or sutures --patients could be randomized to.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Aesculap AG
• Investigators: Principal Investigator: Galen Perdikis, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: April 29, 2009
• First Submitted That Met QC Criteria: April 29, 2009
• First Posted (ESTIMATE): April 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Histoacryl; closure of surgical incisions
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 08-007642