HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

Surgical Incisions Clinical Trial

Official title:

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©.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890578
• Other study ID #: 08-007642
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2009
• Last updated: June 19, 2012
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Incisions

Intervention

Procedure:
• adhesive to suture
surgical closure

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Aesculap AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.		1 year	Yes