Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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

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Wound Closure After Port Catheter Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Suture

Skin incision closure with standard subcuticular technique

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type PROCEDURE

Skin incision closure with standard subcuticular technique

Experimental: Histoacryl®

Skin incision closure with topic skin adhesive Histoacryl®

Group Type ACTIVE_COMPARATOR

Experimental: Histoacryl®

Intervention Type DEVICE

Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)

Interventions

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Suture

Skin incision closure with standard subcuticular technique

Intervention Type PROCEDURE

Experimental: Histoacryl®

Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition

Exclusion Criteria

* Children and adolescents \< 18 years
* Thrombocytes \< 50/nl
* PTT \<50%
* INR \>1.5
* Systemic or local infection of the interventional location
* Known allergy to used material
* Known allergy to Histoacryl, Cyanoacrylate, D\&C Violett or Formaldehyd
* General contraindication of port catheter implantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No