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

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Surgical Drain

Treatments: Device: K-Lock; Other: Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06916286

IRB00128120

Details and patient eligibility

About

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.

Full description

Patients will be identified as potential subjects where the study team will speak with them, determine eligibility, and obtain consent prior to surgery. On the day of surgery, patients will be randomized to either A) drains being secured with the K-Lock device or B) drains being secured with the suture-based technique. All drains will be secured according to randomization.

Postoperatively: The study team will follow the subjects weekly via the electronic medical record documenting (in REDCap) calls made to the triage nurse, visits to the emergency department, requests for additional pain medications, unexpected drain removal, need for additional drain placement, etc. Subjects will return to clinic at their regularly scheduled follow-up appointments with no additional study related activities and will be followed by the study team weekly, via chart review for a total of 3 months from their surgery date. When the subjects return to clinic to have their final drain removed they will be asked to complete a survey asking about their experience with their drains and drain securement. We will also have a blinded evaluator complete a short survey evaluating the skin around the drain insertion site. Photos will be taken of the drain site upon drain removal and again at the 3 month follow-up visit.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Patient of the Department of Plastic and Reconstructive Surgery
• Able to sign English language Consent form
• Undergoing a surgical procedure where placement of one or more surgical drains is anticipated

Exclusion criteria

• Unable to sign English language consent form
• Incompatible drain size placed
• Allergy or sensitivity to skin adhesives

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

K-Lock Device

Experimental group

Description:

K-Lock securement device

Treatment:

Device: K-Lock

Traditional Suture

Active Comparator group

Description:

Traditional suture securement

Treatment:

Other: Suture