HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

NCT ID: NCT00890578

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1-abdominal

half abdominal surgeries (20 patients out of 40)

adhesive to suture

Intervention Type: PROCEDURE

surgical closure

2-breast

half breast surgeries (20 out of 40)

adhesive to suture

Intervention Type: PROCEDURE

surgical closure

Interventions

adhesive to suture

surgical closure

Intervention Type: PROCEDURE

Other Intervention Names

Dermabond, Histoacryl, or sutures --patients could be randomized to.

Eligibility Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Galen Perdikis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

08-007642

Identifier Type: -

Identifier Source: org_study_id