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| ID | Type | Description | Link |
|---|---|---|---|
| PV4003 | Other Identifier | Ethik Kommission der Aerztekammer Hamburg |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leukosan Adhesive | Experimental | Leukosan Adhesive applied to one wound (left or right) |
|
| Transcutaneous suture | Active Comparator | Transcutaneous suture applied to second wound (left or right) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukosan Adhesive | Device | Leukosan adhesive applied to one wound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7-12 days post-operation |
| Intensity of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Buchweitz, Priv.Doz. | Tagesklinik Altonaer Strasse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tagesklinik Altonaer Strasse | Hamburg | 20357 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9154784 | Background | 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. | |
| 12788419 | Background | Matin 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. |
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| Transcutaneous suture | Device | Transcutaneous suture applied to one wound |
|
7-12 days post-operation patients were examined for intensity of pain
| 7-12 days post-operation |
| Investigator's assessment of cosmetic outcome | The Investigator examined patients to assess the cosmetic outcome. | At 3 months post-operation |
| 15549624 | Background | Buchweitz 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. |
| 21333194 | Background | Chen 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. |
| 3450848 | Background | Schuirmann 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. |
| 26428200 | Derived | Buchweitz 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. |