Trials / Completed
CompletedNCT02551510
Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Jena University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Suture | Skin incision closure with standard subcuticular technique |
| DEVICE | Experimental: Histoacryl® | Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer) |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2019-03-01
- Completion
- 2019-05-01
- First posted
- 2015-09-16
- Last updated
- 2020-03-11
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02551510. Inclusion in this directory is not an endorsement.