Surgical Wound DehiscenceNCT01658163
Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh
An observational study of Surgical Wound Dehiscence and Cutis Laxa, run by Medical University of Graz.
Trial summary
The investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Wound Dehiscence, Cutis Laxa, Wound of Skin
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Patients who underwent an abdominoplasty without exclusion criteria
Who cannot join
- current intake of systemic steroids
- known HIV-positive or other immunocompromised status
- known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
- personal or family history of keloid or hypertrophic scar formation
About this study
Official title: Use of 2 Octyl-cyanoacrylate Together With a Self-adhering Mesh for Skin Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
The investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic surgeons and three plastic surgery residents assessed the wound and scar appearance during the three follow-up visits.
Read the detailed description
Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The appearance of the scar is a major factor contributing to the aesthetic outcome of the procedure and depends largely on the technique of wound closure. The new PrineoTM wound closure system was introduced to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh.Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study. Total operating time after abdominoplasty between the traditional wound closure technique and the PrineoTM-type wound closure technique was compared. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 6- and 12-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Twelve months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.There was a statistically significant shorter mean of total operating time for the new skin closure system compared with intradermal sutures. The Hollander Cosmesis Scale indicated a significantly more favourable overall result with PrineoTM at 2 weeks after surgery. The Vancouver Scar Scale demonstrated a better cosmetic outcome in favour of PrineoTM 6 and 12 months after surgery The Patient Scar Assessment Scale scores 12 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on our results, we conclude that PrineoTM is a safe and effective substitute for superficial skin closure, with good cosmetic results and no increase in wound complications. The use of PrineoTM decreases operative times and costs and enhances patients' postoperative comfort.
- Conditions
- Surgical Wound Dehiscence, Cutis Laxa, Wound of Skin
- Keywords
- abdominoplasty,, skin closure, dressings
- Medical subject headings
- Surgical Wound Dehiscence, Cutis Laxa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJun 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound DehiscenceStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daryousch Parvizi, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658163
- Sponsor's protocol ID
- Prineo
- Status last verified
- Jan 2013
- First submitted
- 9 May 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 2 Octyl-cyanoacrylate Together With a Self-adhering Mesh for Skin Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01658163
- Acronym / sponsor ID
- Prineo
- Conditions
- Surgical Wound Dehiscence, Cutis Laxa, Wound of Skin
- Keywords
- abdominoplasty,, skin closure, dressings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2009
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Aug 2012 (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 investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic surgeons and three plastic surgery residents assessed the wound and scar appearance during the three follow-up visits.
Detailed description
Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The appearance of the scar is a major factor contributing to the aesthetic outcome of the procedure and depends largely on the technique of wound closure. The new PrineoTM wound closure system was introduced to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh.Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study. Total operating time after abdominoplasty between the traditional wound closure technique and the PrineoTM-type wound closure technique was compared. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 6- and 12-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Twelve months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.There was a statistically significant shorter mean of total operating time for the new skin closure system compared with intradermal sutures. The Hollander Cosmesis Scale indicated a significantly more favourable overall result with PrineoTM at 2 weeks after surgery. The Vancouver Scar Scale demonstrated a better cosmetic outcome in favour of PrineoTM 6 and 12 months after surgery The Patient Scar Assessment Scale scores 12 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on our results, we conclude that PrineoTM is a safe and effective substitute for superficial skin closure, with good cosmetic results and no increase in wound complications. The use of PrineoTM decreases operative times and costs and enhances patients' postoperative comfort.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Patients who underwent an abdominoplasty without exclusion criteria
Key exclusion criteria (4 listed)
- current intake of systemic steroids
- known HIV-positive or other immunocompromised status
- known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
- personal or family history of keloid or hypertrophic scar formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Jan 2013.
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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.
Daryousch Parvizi, MD principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Dehiscence and Cutis Laxa, run by Medical University of Graz.
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 1 inclusion and 4 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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 7 Jan 2013.