NCT04848389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

March 23, 2021

Last Update Submit

September 11, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

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

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

    1 month

Secondary Outcomes (2)

  • Physical shape of the scar (POSAS scale)

    1 month

  • Patient's comfort

    30 days

Study Arms (2)

Skin adhesive

EXPERIMENTAL

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.

Procedure: Skin Adhesive procedure

Standard suture

OTHER

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.

Procedure: Standard suture procedure

Interventions

Skin Adhesive procedurePROCEDURE

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
Standard suture procedurePROCEDURE

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.

Standard suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

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

Location

Related Publications (6)

  • 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.

    PMID: 25604588BACKGROUND

  • 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.

    PMID: 23613192BACKGROUND

  • 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.

    PMID: 18594354BACKGROUND

  • 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.

    PMID: 27836404BACKGROUND

  • 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.

    PMID: 18090752BACKGROUND

  • 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.

    PMID: 27495928BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lynda SALMI, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

April 19, 2021

Study Start

April 1, 2021

Primary Completion

February 3, 2022

Study Completion

April 30, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

FR(1)