Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions

NCT02212977 | Completed Results

• 1 other identifier: Pro00056064
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.

Conditions

Port-A-Cath Placement; Octylcyanoacrylate

Keywords

Port Catheter; Octyl 2-cyanoacrylate; 2-octylcyanoacrylate

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Complication of Wound Dehiscence

  To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

  3 months

• Number of Participants With Complication of Infection

  To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

  3 months

Secondary Outcomes (3)

• Healing-incision Cosmesis Score by Visual Analogue Scale

  3 months

• Closure Time

  Baseline

• Closure Materials Cost

  Baseline

Study Arms (2)

Suture

ACTIVE COMPARATOR

Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture

Procedure: Suture

Octylcyanoacrylate

EXPERIMENTAL

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Device: Octylcyanoacrylate

Interventions

Octylcyanoacrylate DEVICE

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Also known as: Octyl 2-cyanoacrylate, 2-octylcyanoacrylate

Octylcyanoacrylate

Suture PROCEDURE

Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture

Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study

You may not qualify if:

• Patients who cannot provide informed consent for the procedure will be excluded from the study.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Small sample size, underpowered to demonstrate small differences in rates of dehiscence or infection.

Results Point of Contact

• Title: Dr. Charles Kim
• Organization: Duke University Medical Center

charles.kim@duke.edu

9196847424

Study Officials

• Charles Kim, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 18, 2016
• Results First Posted: October 18, 2016

Record last verified: 2016-10

Locations

US (1)