Late Effects of Open WoundNCT01544556
Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty
An observational study of Late Effects of Open Wound, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Late Effects of Open Wound
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Feb 2012
- 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: Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study.
Who may be able to join
None listed.
Who cannot join
- peripheral vascular disease; insulin dependent diabetes mellitus; 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; or additional surgical procedures performed in the same surgical session in the same anatomical region. -
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery,Medical University of Graz, Austria
Graz, Styria, 8036
About this study
Official title: Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
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 investigators routinely used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure. To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives were introduced as a new technology. The new PrineoTM wound closure system was created to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh to make closure of long skin incisions even more safe and reliable. PrineoTM has the potential to offer a patient several benefits over traditional wound closure with sutures.A patient treated with Prineo™ can shower immediately following a procedure because the product forms a watertight barrier over the incision. PrineoTM can be easily removed, often with less pain than is sometimes associated with suture removal, after the natural wound healing process is complete (approximately 12 to 25 days). Other benefits are that it forms a microbial barrier and provides even distribution of tension across the length of the incision to ensure wound edge approximation throughout the wound healing process. Furthermore, it reduces subcuticular closure time as compared to subcuticular suturing.
However, these potential advantages have not been proven until now, as the methods used to assess the aesthetic outcome were not reproducible in most assessments, and none of these studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical patient population. For these reasons, 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.
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. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 3- and 6-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Six months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.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 3 and 6 months after surgery The Patient Scar Assessment Scale scores 6 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on the investigators results, the investigators 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 enhances patients' postoperative comfort
- Conditions
- Late Effects of Open Wound
- Keywords
- abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prineo | An open, prospective, controlled, randomized clinical Study | |
| Steristrips | An open, prospective, controlled, randomized clinical Study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Effects of Open WoundStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryousch Parvizi, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544556
- Sponsor's protocol ID
- Prineo 1
- Other IDs
- Prineo2
- Status last verified
- Feb 2012
- First submitted
- 29 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01544556
- Acronym / sponsor ID
- Prineo 1
- Conditions
- Late Effects of Open Wound
- Keywords
- abdominoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Mar 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.
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 investigators routinely used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure. To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives were introduced as a new technology. The new PrineoTM wound closure system was created to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh to make closure of long skin incisions even more safe and reliable. PrineoTM has the potential to offer a patient several benefits over traditional wound closure with sutures.A patient treated with Prineo™ can shower immediately following a procedure because the product forms a watertight barrier over the incision. PrineoTM can be easily removed, often with less pain than is sometimes associated with suture removal, after the natural wound healing process is complete (approximately 12 to 25 days). Other benefits are that it forms a microbial barrier and provides even distribution of tension across the length of the incision to ensure wound edge approximation throughout the wound healing process. Furthermore, it reduces subcuticular closure time as compared to subcuticular suturing.
However, these potential advantages have not been proven until now, as the methods used to assess the aesthetic outcome were not reproducible in most assessments, and none of these studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical patient population. For these reasons, 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.
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. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 3- and 6-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Six months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.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 3 and 6 months after surgery The Patient Scar Assessment Scale scores 6 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on the investigators results, the investigators 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 enhances patients' postoperative comfort
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prineo | – | –An open, prospective, controlled, randomized clinical Study |
| Steristrips | – | –An open, prospective, controlled, randomized clinical Study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- peripheral vascular disease; insulin dependent diabetes mellitus; 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; or additional surgical procedures performed in the same surgical session in the same anatomical region. -
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 6 Mar 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Late Effects of Open Wound, run by Medical University of Graz at 1 site in Austria.
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 0 inclusion and 1 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 6 Mar 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 Austria. 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.
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 6 Mar 2012.