RECRUITING

Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to evaluate whether surgical drain securement with a novel sutureless device (K-LOCKTM) will improve patient quality of life and reduce postoperative drain-related complications compared to drain securement with traditional suture-based methods. The K-LOCK™ Device is a novel sutureless drain securement device that may improve patient experiences with surgical drains.

Official Title

A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications

Quick Facts

Study Start:2025-05-05
Study Completion:2027-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06916286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Patient of the Department of Plastic and Reconstructive Surgery
  3. * Able to sign English language Consent form
  4. * Undergoing a surgical procedure where placement of one or more surgical drains is anticipated
  1. * Unable to sign English language consent form
  2. * Incompatible drain size placed
  3. * Allergy or sensitivity to skin adhesives

Contacts and Locations

Study Contact

Renea D Jennings, BSN,RN,CCRP
CONTACT
336-716-6709
rjenning@wakehealth.edu
Caleb T Suggs, CCRP
CONTACT
336-713-4339
csuggs@wakehealth.edu

Principal Investigator

Bennett W Calder, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Bennett W Calder, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05
Study Completion Date2027-05-30

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2027-05-30

Terms related to this study

Keywords Provided by Researchers

  • Drain Insertion Site
  • Drain Site Complication
  • Plastic and Reconstructive Surgery

Additional Relevant MeSH Terms

  • Surgical Drain