HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

NCT00890578 | Completed

• 1 other identifier: 08-007642
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Incisions

Keywords

Histoacryl; closure of surgical incisions

Outcome Measures

Primary Outcomes (1)

• Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.

  1 year

Study Arms (2)

1-abdominal

half abdominal surgeries (20 patients out of 40)

Procedure: adhesive to suture

2-breast

half breast surgeries (20 out of 40)

Procedure: adhesive to suture

Interventions

adhesive to suture PROCEDURE

surgical closure

Also known as: Dermabond, Histoacryl, or sutures --patients could be randomized to.

1-abdominal; 2-breast

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Abdominoplasty or panniculectomy patients:
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Aesculap AG: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

octyl 2-cyanoacrylate; Enbucrilate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyanoacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Galen Perdikis, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: April 30, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

US (1)