Wound Healing Cosmetic ResultNCT02179723
Clinical Study Into the Cosmetic Results of Leukosan Adhesive
A study testing Leukosan Adhesive and Transcutaneous suture in people with Wound Healing Cosmetic Result, run by Dr. Stephanie Krause at 1 site in Germany.
Trial summary
This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Wound Healing Cosmetic Result
- What is being tested?
- Leukosan Adhesive and Transcutaneous suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Jul 2013
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between 18 and 60
- Undergone laparoscopic operation with 2 mirror image trocar incisions
- Willing to attend examination at clinic at 7-12 days and 10-14 weeks
- Signed agreement by participant
Who cannot join
- Length of laparoscopic operation more than 2 hours
- Hospitalisation due to complications
- Circumstances leading to difference in trocar incisions
- Existing scar less than 3 cm from the operation point
- Diabetic condition melitis HbA1c>9mg/d
- Known allergy to tissue adhesive
- Participation in another study within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision
This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures.
In particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with Leuksan Adhesive.
An open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of March 2013 and April 2013.
Read the detailed description
The medical devices compared were EU (European Union) approved market-ready products with relevant designation according to the legal requirements for medical devices and according to Council guideline 93/42/EWG dated 14th July.
Leukosan Adhesive is a sterile, ultra high viscose adhesive for external skin closure. Due to the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film firmly holding the edges of the wound together and protecting the wound itself.
Premilene DSMP 24, 3/8 needle, thread 3/0 denier was used a a comparison. This suture material was the standard suture material used in the study centre.
- Conditions
- Wound Healing Cosmetic Result
- Being tested
- Leukosan Adhesive, Transcutaneous suture
- Keywords
- wound healing, cosmetic results, trocar incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukosan AdhesiveDevice
Leukosan adhesive applied to one wound
Transcutaneous sutureDevice
Transcutaneous suture applied to one wound
| Study group | Role | What they receive |
|---|---|---|
| Leukosan Adhesive | Experimental | Leukosan Adhesive applied to one wound (left or right) Receives: Device: Leukosan Adhesive; Device: Transcutaneous suture |
| Transcutaneous suture | Active comparator | Transcutaneous suture applied to second wound (left or right) Receives: Device: Leukosan Adhesive; Device: Transcutaneous suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction with cosmetic appearance/result of the wound
The primary outcome was the satisfaction of the patients with the cosmetic result of the wound healing after 3 months. This was measured by a visual analogue scale. In order to validate this result, an additional known wound assessment instrument, an ordinal scaled index, was implemented and the assessment of independent assessors was called on.
Measured: 3 months post operation
Secondary outcomes (3)
The incidence of complication
7-12 days post-operation patients were examined for complications in treatment such as wound dehiscence, maceration, redness, overheating and pain
Measured: 7-12 days post-operation
Intensity of pain
7-12 days post-operation patients were examined for intensity of pain
Measured: 7-12 days post-operation
Investigator's assessment of cosmetic outcome
The Investigator examined patients to assess the cosmetic outcome.
Measured: At 3 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Wound Healing Cosmetic ResultStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Stephanie Krause
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Stephanie Krause, BSN Medical GmbH
- Investigators
- Olaf Buchweitz, Priv.Doz., Principal investigator, Tagesklinik Altonaer Strasse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179723
- Sponsor's protocol ID
- BSNMedicalC09962
- Other IDs
- PV4003
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51. doi: 10.1016/s1074-3804(05)80226-9.
PubMed 9154784Matin SF. Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions. J Am Coll Surg. 2003 Jun;196(6):845-53. doi: 10.1016/s1072-7515(03)00119-4.
PubMed 12788419Buchweitz O, Wulfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.
PubMed 15549624Chen K, Klapper AS, Voige H, Del Priore G. A randomized, controlled study comparing two standardized closure methods of laparoscopic port sites. JSLS. 2010 Jul-Sep;14(3):391-4. doi: 10.4293/108680810X12924466006729.
PubMed 21333194Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PubMed 3450848Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.
PubMed 26428200
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision
- ClinicalTrials.gov ID
- NCT02179723
- Acronym / sponsor ID
- BSNMedicalC09962
- Conditions
- Wound Healing Cosmetic Result
- Keywords
- wound healing, cosmetic results, trocar incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Dr. Stephanie KrauseIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Jul 2014 (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.
This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures.
In particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with Leuksan Adhesive.
An open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of March 2013 and April 2013.
Detailed description
The medical devices compared were EU (European Union) approved market-ready products with relevant designation according to the legal requirements for medical devices and according to Council guideline 93/42/EWG dated 14th July.
Leukosan Adhesive is a sterile, ultra high viscose adhesive for external skin closure. Due to the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film firmly holding the edges of the wound together and protecting the wound itself.
Premilene DSMP 24, 3/8 needle, thread 3/0 denier was used a a comparison. This suture material was the standard suture material used in the study centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukosan Adhesive | Experimental | Device: Leukosan Adhesive, Device: Transcutaneous sutureLeukosan Adhesive applied to one wound (left or right) |
| Transcutaneous suture | Active comparator | Device: Leukosan Adhesive, Device: Transcutaneous sutureTranscutaneous suture applied to second wound (left or right) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female between 18 and 60
- Undergone laparoscopic operation with 2 mirror image trocar incisions
- Willing to attend examination at clinic at 7-12 days and 10-14 weeks
- Signed agreement by participant
Key exclusion criteria (7 listed)
- Length of laparoscopic operation more than 2 hours
- Hospitalisation due to complications
- Circumstances leading to difference in trocar incisions
- Existing scar less than 3 cm from the operation point
- Diabetic condition melitis HbA1c>9mg/d
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 |
|---|---|---|
| Leukosan AdhesiveLeukosan adhesive applied to one wound | Device | Leukosan Adhesive, Transcutaneous suture |
| Transcutaneous sutureTranscutaneous suture applied to one wound | Device | Leukosan Adhesive, Transcutaneous suture |
Primary outcome
Patient's satisfaction with cosmetic appearance/result of the wound
Time frame: 3 months post operation
The primary outcome was the satisfaction of the patients with the cosmetic result of the wound healing after 3 months. This was measured by a visual analogue scale. In order to validate this result, an additional known wound assessment instrument, an ordinal scaled index, was implemented and the assessment of independent assessors was called on.
3 secondary outcomes
The incidence of complication
Time frame: 7-12 days post-operation
Intensity of pain
Time frame: 7-12 days post-operation
Investigator's assessment of cosmetic outcome
Time frame: At 3 months post-operation
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 2 Jul 2014.
- Background: PubMed 9154784Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51. doi: 10.1016/s1074-3804(05)80226-9.
- Background: PubMed 12788419Matin SF. Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions. J Am Coll Surg. 2003 Jun;196(6):845-53. doi: 10.1016/s1072-7515(03)00119-4.
- Background: PubMed 15549624Buchweitz O, Wulfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.
- Background: PubMed 21333194Chen K, Klapper AS, Voige H, Del Priore G. A randomized, controlled study comparing two standardized closure methods of laparoscopic port sites. JSLS. 2010 Jul-Sep;14(3):391-4. doi: 10.4293/108680810X12924466006729.
- Background: PubMed 3450848Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
- Derived from this study: PubMed 26428200Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.
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.
Olaf Buchweitz, Priv.Doz. principal investigator
Tagesklinik Altonaer Strasse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukosan Adhesive and Transcutaneous suture in people with Wound Healing Cosmetic Result, run by Dr. Stephanie Krause at 1 site in Germany.
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 4 inclusion and 7 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 2 Jul 2014. 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 Germany. 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?
Patient's satisfaction with cosmetic appearance/result of the wound (time frame: 3 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179723, which also lists 6 linked publications.
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 2 Jul 2014.