Optimization of the Nursing Time After the Use of Tissue Adhesives During the Chest Port Placement on Patients Treated With Chemotherapy Versus Sutures
NCT ID: NCT04848389
Last Updated: 2023-09-13
Study Results
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Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2021-04-01
2023-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Skin adhesive
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.
Skin Adhesive 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
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 with the same thread with a subcutaneous stitch.
Standard suture 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.
Interventions
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Skin Adhesive 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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Lynda SALMI, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, France
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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PAC_COLLE
Identifier Type: -
Identifier Source: org_study_id
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