HISTOACRYL: A Study of Its Efficacy in Final Scar Formation - Full Text View

Sponsors and Collaborators:	Mayo Clinic Aesculap AG
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00890578

Purpose

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	Intervention	Phase
Surgical Incisions	Procedure: adhesive to suture	Phase IV

MedlinePlus related topics: Scars Surgery

Drug Information available for: Enbucrilate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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©.

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2009

Groups/Cohorts	Assigned Interventions
1-abdominal half abdominal surgeries (20 patients out of 40)	Procedure: adhesive to suture surgical closure
2-breast half breast surgeries (20 out of 40)	Procedure: adhesive to suture surgical closure

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890578

Contacts

Contact: Erika E. Elmer, BA, CCRP	904-953-2255	elmer.erika@mayo.edu
Contact: Kellie Ruday, BA	904-953-2255

Locations

United States, Florida
Mayo Clinic Florida	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Erika E. Elmer, BA, CCRP

Sponsors and Collaborators

Mayo Clinic

Aesculap AG

Investigators

Principal Investigator:

Galen Perdikis, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Galen Perdikis, M.D. )
Study ID Numbers:	08-007642
Study First Received:	April 29, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00890578 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Histoacryl
closure of surgical incisions

Study placed in the following topic categories:

Cicatrix

ClinicalTrials.gov processed this record on May 07, 2009