Status:
COMPLETED
HISTOACRYL: A Study of Its Efficacy in Final Scar Formation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Aesculap AG
Conditions:
Surgical Incisions
Eligibility:
FEMALE
21+ years
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 deh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00890578
Start Date
April 1 2009
End Date
February 1 2011
Last Update
June 21 2012
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224