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Clinical Trials/NCT04848389
NCT04848389CompletedNot Applicable

Optimization of the Nursing Time After the Use of Tissue Adhesives During the Chest Port Placement on Patients Treated With Chemotherapy, a Randomized Trial Versus Sutures

Fondation Hôpital Saint-Joseph2 sites in 1 country71 target enrollmentStarted: April 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
71
Locations
2
Primary Endpoint
The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion)

Study Overview

Brief Summary

Skin adhesive (Octyl cyanoacrylate - LIQUID BAND©) is increasingly used instead of suture for sutures on the superficial plane of the skin.

It is frequently used in children, in traumatology and in plastic surgery. Several randomized trials have shown satisfactory results of the glue compared to suture in terms of infections and scar dehiscence, and aesthetics after abdominoplasty and mammoplasty.

In the field of port-a-cath® placement in oncology:

  • The use of skin adhesive can save substantial nursing time, which makes it possible to consider the transition of this technique into routine patient management. Potential benefits include nurses managing large numbers of patients in day hospitals, and patients no longer needing a nurse for suture removal.
  • Cancer and chemotherapy toxicity can alter patients' body image and view of themselves. The presence of a scar can be traumatic for some patients. The second goal of this study is to test whether the use of glue can improve the appearance of the scar following port-a-cath® placement, an area in which there are divergent results.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient with age ≥ 18 years
  • Patient followed in day hospitalization in Oncology
  • Patient requiring a first CP for chemotherapy
  • Patient affiliated to a healthcare system
  • French-speaking patient
  • Patient who has given his free, informed and express oral consent

Exclusion Criteria

  • Patient followed in the Pneumology department
  • Patient treated outside the GHPSJ
  • Patient with a CP for another indication than chemotherapy (nutrition, antibiotic therapy)
  • Patients with comprehension problems
  • Patients with behavior issues
  • Pregnant women
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection

Outcomes

Primary Outcomes

The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion)

Time Frame: 1 month

This outcome corresponds to the Timed nursing time for PAC infusion in the first cycle of chemotherapy and comparison between the 2 arms.

Secondary Outcomes

  • Patient's comfort(30 days)
  • Physical shape of the scar (POSAS scale)(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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