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Completed

NCT Number: NCT04848389

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Adhesive procedure

Procedure

The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable 3/0 vicryl-type thread, the cutaneous plane is closed by applying skin adhesive. A drying time of 25 seconds is necessary to obtain a satisfactory seal.

Standard suture procedure

Procedure

The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable thread of the 3/0 Vicryl-type, the cutaneous plane is closed with the same thread with an subcutaneous stitch.

Primary outcomes

  1. 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

  1. Physical shape of the scar (POSAS scale)

    Time frame: 1 month

    This outcome correspond to the POSAS scale which is a reliable and valid scar assessment scale that measures scar quality from two perspectives: the patient and the clinician. The POSAS measures scar quality in all types of scars. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  2. Patient's comfort

    Time frame: 30 days

    This outcome correspond to the assessment of the patient's comfort at D30 during the implantation with the tissue adhesive comparing to the sutures.1. In the time between the installation of PAC and visit , did patient use for PAC? a home health aide or a nurse? 2. Did patient visit his general practitioner in this interval for your PAC? Yes or No 3. On a scale of 0 to 10, what pain are patient experiencing today? 4. On a scale of 0 to 10, how much discomfort are patient experiencing today? 5. Following PACplacement, how soon were patient able to resume showering in days? 6. Following the placement of the PAC, how soon were patient able to resume a normal life in days?

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

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

Acronym: PAC_COLLE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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