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AzTrials

CancerPAC_COLLENCT04848389

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

A study testing Skin Adhesive procedure and Standard suture procedure in people with Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Skin Adhesive procedure and Standard suture procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteFrance
Study dates
1 Apr 2021to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, Groupe Hospitalier Paris Saint-Joseph, 75014

Other trials in France

About this study

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

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.

Read more

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.
Conditions
Cancer
Being tested
Skin Adhesive procedure, Standard suture procedure
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin Adhesive procedureProcedure or surgery

    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 procedureProcedure or surgery

    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.

Study groups in NCT04848389
Study groupRoleWhat they receive
Skin adhesiveExperimentalThe 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.
Receives: Procedure: Skin Adhesive procedure
Standard sutureOtherThe 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.
Receives: Procedure: Standard suture procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (2)

  1. Physical shape of the scar (POSAS scale)

    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.

    Measured: 1 month

  2. Patient's comfort

    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?

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion3 Feb 2022
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04848389
Sponsor's protocol ID
PAC_COLLE
Acronym
PAC_COLLE
Status last verified
Sep 2023
First submitted
23 Mar 2021
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25604588

  • 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.

    PubMed 23613192

  • 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.

    PubMed 18594354

  • 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.

    PubMed 27836404

  • 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.

    PubMed 18090752

  • 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.

    PubMed 27495928

Questions about this trial

What is this clinical trial studying?

A study testing Skin Adhesive procedure and Standard suture procedure in people with Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04848389, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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