Clinical trial NCT04848389: Optimization of the Nursing Time After the Use of Tissue Adhesives During the Chest Port Placement on Patients Treated With Chemotherapy Versus Sutures
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion)
timeFrame: 1 month
Secondary outcomes:
measure: Physical shape of the scar (POSAS scale)
timeFrame: 1 month
measure: Patient's comfort
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
state: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Lynda SALMI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vida VL, Barzon E, Sabiu C, De Franceschi M, Padalino MA, Stellin G. The use of "2-octyl cyanoacrylate" as skin adhesive in pediatric and congenital cardiac surgery. Minerva Pediatr. 2015 Apr;67(2):111-6. Epub 2015 Jan 21.
citation: Parvizi D, Friedl H, Schintler MV, Rappl T, Laback C, Wiedner M, Vasiljeva A, Kamolz LP, Spendel S. Use of 2-octyl cyanoacrylate together with a self-adhering mesh (Dermabond Prineo) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study. Aesthetic Plast Surg. 2013 Jun;37(3):529-37. doi: 10.1007/s00266-013-0123-3. Epub 2013 Apr 24.
citation: Nipshagen MD, Hage JJ, Beekman WH. Use of 2-octyl-cyanoacrylate skin adhesive (Dermabond) for wound closure following reduction mammaplasty: a prospective, randomized intervention study. Plast Reconstr Surg. 2008 Jul;122(1):10-18. doi: 10.1097/PRS.0b013e318171524b.
citation: Martin JG, Hollenbeck ST, Janas G, Makar RA, Pabon-Ramos WM, Suhocki PV, Miller MJ, Sopko DR, Smith TP, Kim CY. Randomized Controlled Trial of Octyl Cyanoacrylate Skin Adhesive versus Subcuticular Suture for Skin Closure after Implantable Venous Port Placement. J Vasc Interv Radiol. 2017 Jan;28(1):111-116. doi: 10.1016/j.jvir.2016.08.009. Epub 2016 Nov 9.
citation: Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
citation: Liberale G, El Houkayem M, Viste C, Bouazza F, Moreau M, El Nakadi I, Veys I. Evaluation of the perceptions and cosmetic satisfaction of breast cancer patients undergoing totally implantable vascular access device (TIVAD) placement. Support Care Cancer. 2016 Dec;24(12):5035-5040. doi: 10.1007/s00520-016-3368-y. Epub 2016 Aug 5.