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| Name | Class |
|---|---|
| Aesculap AG | INDUSTRY |
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Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture | Active Comparator | Skin incision closure with standard subcuticular technique |
|
| Experimental: Histoacryl® | Active Comparator | Skin incision closure with topic skin adhesive Histoacryl® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture | Procedure | Skin incision closure with standard subcuticular technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic outcome after wound healing | Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation | 8 weeks |
| Cosmetic outcome after wound healing | Patient and observer scar assessment scale (POSAS) | 8 weeks |
| Cosmetic outcome after wound healing | Life quality questionnaire EQ5D | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate | Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien) | 8 weeks |
| Economy of time for wound closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Jena | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34615593 | Derived | Witting S, Ingwersen M, Lehmann T, Aschenbach R, Eckardt N, Zanow J, Fahrner R, Lotze S, Friedel R, Lenz M, Schmidt C, Miguel D, Ludriksone L, Teichgraber U. Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing. Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324. |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Experimental: Histoacryl® |
| Device |
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer) |
|
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
| 10 minutes |