Wound Closure After Port Catheter ImplantationPWCNCT02551510
Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
A study testing Suture and Experimental: Histoacryl® in people with Wound Closure After Port Catheter Implantation, run by Jena University Hospital at 1 site in Germany.
Trial summary
Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure After Port Catheter Implantation
- What is being tested?
- Suture and Experimental: Histoacryl®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to May 2019
- 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
- Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition
Who cannot join
- Children and adolescents < 18 years
- Thrombocytes < 50/nl
- PTT <50%
- INR >1.5
- Systemic or local infection of the interventional location
- Known allergy to used material
- Known allergy to Histoacryl, Cyanoacrylate, D\&C Violett or Formaldehyd
- General contraindication of port catheter implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection
Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
Read the detailed description
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
- Being tested
- Suture, Experimental: Histoacryl®
- Keywords
- Skin Adhesive, Suture, Port Incisions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureProcedure or surgery
Skin incision closure with standard subcuticular technique
Experimental: Histoacryl®Device
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Skin incision closure with standard subcuticular technique Receives: Procedure: Suture |
| Experimental: Histoacryl® | Active comparator | Skin incision closure with topic skin adhesive Histoacryl® Receives: Device: Experimental: Histoacryl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome after wound healing
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
Measured: 8 weeks
Cosmetic outcome after wound healing
Patient and observer scar assessment scale (POSAS)
Measured: 8 weeks
Cosmetic outcome after wound healing
Life quality questionnaire EQ5D
Measured: 8 weeks
Secondary outcomes (2)
Infection rate
Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)
Measured: 8 weeks
Economy of time for wound closure
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Closure After Port Catheter ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551510
- Sponsor's protocol ID
- 4164-07/14
- Acronym
- PWC
- Status last verified
- Mar 2020
- First submitted
- 17 Aug 2015
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Witting S, Ingwersen M, Lehmann T, Aschenbach R, Eckardt N, Zanow J, Fahrner R, Lotze S, Friedel R, Lenz M, Schmidt C, Miguel D, Ludriksone L, Teichgraber U. Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing. Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324.
PubMed 34615593
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection
- ClinicalTrials.gov ID
- NCT02551510
- Acronym / sponsor ID
- PWC / 4164-07/14
- Keywords
- Skin Adhesive, Suture, Port Incisions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
Detailed description
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: SutureSkin incision closure with standard subcuticular technique |
| Experimental: Histoacryl® | Active comparator | Device: Experimental: Histoacryl®Skin incision closure with topic skin adhesive Histoacryl® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition
Key exclusion criteria (8 listed)
- Children and adolescents < 18 years
- Thrombocytes < 50/nl
- PTT <50%
- INR >1.5
- Systemic or local infection of the interventional location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutureSkin incision closure with standard subcuticular technique | Procedure or surgery | Suture |
| Experimental: Histoacryl®Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer) | Device | Experimental: Histoacryl® |
Primary outcome
Cosmetic outcome after wound healing
Time frame: 8 weeks
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
Cosmetic outcome after wound healing
Time frame: 8 weeks
Patient and observer scar assessment scale (POSAS)
Cosmetic outcome after wound healing
Time frame: 8 weeks
Life quality questionnaire EQ5D
2 secondary outcomes
Infection rate
Time frame: 8 weeks
Economy of time for wound closure
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 34615593Witting S, Ingwersen M, Lehmann T, Aschenbach R, Eckardt N, Zanow J, Fahrner R, Lotze S, Friedel R, Lenz M, Schmidt C, Miguel D, Ludriksone L, Teichgraber U. Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing. Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture and Experimental: Histoacryl® in people with Wound Closure After Port Catheter Implantation, run by Jena University Hospital at 1 site in Germany.
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 1 inclusion and 8 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 11 Mar 2020. 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 Germany. 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?
Cosmetic outcome after wound healing (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT02551510, which also lists 1 linked publication.
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 11 Mar 2020.