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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02551510

Acronym

PWC

Enrollment

128

Registered

2015-09-16

Start date

2015-08-31

Completion date

2019-05-31

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Closure After Port Catheter Implantation

Keywords

Skin Adhesive, Suture, Port Incisions

Brief 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.

Interventions

PROCEDURESuture

Skin incision closure with standard subcuticular technique

DEVICEExperimental: Histoacryl®

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cosmetic outcome after wound healing	8 weeks	Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation

Secondary

Measure	Time frame	Description
Infection rate	8 weeks	Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)
Economy of time for wound closure	10 minutes	Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026