Clinical trial NCT00890578: HISTOACRYL: A Study of Its Efficacy in Final Scar Formation
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Incisions
Keywords: Histoacryl
closure of surgical incisions
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Aesculap AG
First posted: 2009-04-30
Enrollment: 21
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.
  * 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

Primary outcomes:
measure: Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Galen Perdikis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: