Surgical IncisionsNCT00890578
HISTOACRYL: A Study of Its Efficacy in Final Scar Formation
An observational study of Surgical Incisions, run by Mayo Clinic at 1 site in United States.
Trial 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©. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Incisions
- What is being tested?
- adhesive to suture
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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©.
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.
- Conditions
- Surgical Incisions
- Being tested
- adhesive to suture
- Keywords
- Histoacryl, closure of surgical incisions
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adhesive to sutureProcedure or surgery
Also called Dermabond, Histoacryl, or sutures --patients could be randomized to.
surgical closure
| Study group | Role | What they receive |
|---|---|---|
| 1-abdominal | half abdominal surgeries (20 patients out of 40) Receives: Procedure: adhesive to suture | |
| 2-breast | half breast surgeries (20 out of 40) Receives: Procedure: adhesive to suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Investigators
- Galen Perdikis, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890578
- Sponsor's protocol ID
- 08-007642
- Status last verified
- Jun 2012
- First submitted
- 29 Apr 2009
- Last updated
- 21 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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©.
- ClinicalTrials.gov ID
- NCT00890578
- Acronym / sponsor ID
- 08-007642
- Conditions
- Surgical Incisions
- Keywords
- Histoacryl, closure of surgical incisions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-abdominal | – | Procedure: adhesive to suturehalf abdominal surgeries (20 patients out of 40) |
| 2-breast | – | Procedure: adhesive to suturehalf breast surgeries (20 out of 40) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Abdominoplasty or panniculectomy patients:
Key exclusion criteria (11 listed)
- 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:
- Patients who have a known sensitivity to adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adhesive to sutureAlso: Dermabond, Histoacryl, or sutures --patients could be randomized to.surgical closure | Procedure or surgery | 1-abdominal, 2-breast |
Primary outcome
Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen Perdikis, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Incisions, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Histoacryl© to Dermabond© is lacking. Investigation of Histoacryl© in direct comparison to Dermabond© as well as to suture. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.