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CompletedNCT00890578Updated Jun 21, 2012

HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

An observational study in Surgical Incisions, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-21.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
21 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Surgical Incisions

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Keywords

  • Histoacryl
  • closure of surgical incisions
03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 21 is below the median of 117 across 82 observational studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (actual)

Groups and cohorts

  • 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

  • Procedureadhesive to suture

    surgical closure

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

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What researchers measure

Primary outcomes

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

    Time frame: 1 year

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Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00890578
Lead sponsor
Mayo Clinic
Collaborators
Aesculap AG
First posted
Apr 30, 2009
Start date
Apr 2009
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jun 21, 2012

Study contacts

Galen Perdikis, M.D.
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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