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HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00890578
Collaborator
Aesculap AG (Industry)
21
Enrollment
1
Location
22
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: adhesive to suture

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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©.
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm 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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic
    • Aesculap AG

    Investigators

    • Principal Investigator: Galen Perdikis, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00890578
    Other Study ID Numbers:
    • 08-007642
    First Posted:
    Apr 30, 2009
    Last Update Posted:
    Jun 21, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by , ,
    Histoacryl
    closure of surgical incisions
    Additional relevant MeSH terms:
    Surgical Wound

    Study Results

    No Results Posted as of Jun 21, 2012