Surgical DrainNCT06916286
Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
A study testing K-Lock and Suture in people with Surgical Drain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Drain
- What is being tested?
- K-Lock and Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Unable to sign English language consent form
- Incompatible drain size placed
- Allergy or sensitivity to skin adhesives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the detailed 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.
- Conditions
- Surgical Drain
- Being tested
- K-Lock, Suture
- Keywords
- Drain Insertion Site, Drain Site Complication, Plastic and Reconstructive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-LockDevice
Surgical drain securement with a novel sutureless K-LOCK device
SutureOther
Surgical drain securement with traditional suture-based methods
| Study group | Role | What they receive |
|---|---|---|
| K-Lock Device | Experimental | K-Lock securement device Receives: Device: K-Lock |
| Traditional Suture | Active comparator | Traditional suture securement Receives: Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcome Measure Score
Patient reported outcome measures questionnaire will be completed by participant. Total score ranges from 6-30 with a higher score indicating a higher level of patient satisfaction.
Measured: Month 3
Secondary outcomes (2)
Number of Complications
Number of complications including calls to triage nurse, visits to Emergency Room, requests for additional pain medication, early loss of drain.
Measured: Month 3
Rating of Drain Exit Sites
Questionnaire to be completed by a health care team member who is blinded to drain securement method. Drain site will be inspected for erythema, irritation, blistering, maceration, etc. and rated after removal of the drain. Ratings will range from 0-4 with higher rating indicating more severity.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start5 May 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical DrainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Bennett W Calder, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916286
- Sponsor's protocol ID
- IRB00128120
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916286
- Acronym / sponsor ID
- IRB00128120
- Conditions
- Surgical Drain
- Keywords
- Drain Insertion Site, Drain Site Complication, Plastic and Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Study start
- 5 May 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| K-Lock Device | Experimental | Device: K-LockK-Lock securement device |
| Traditional Suture | Active comparator | Other: SutureTraditional suture securement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to sign English language consent form
- Incompatible drain size placed
- Allergy or sensitivity to skin adhesives
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 |
|---|---|---|
| K-LockSurgical drain securement with a novel sutureless K-LOCK device | Device | K-Lock Device |
| SutureSurgical drain securement with traditional suture-based methods | Other | Traditional Suture |
Primary outcome
Patient-Reported Outcome Measure Score
Time frame: Month 3
Patient reported outcome measures questionnaire will be completed by participant. Total score ranges from 6-30 with a higher score indicating a higher level of patient satisfaction.
2 secondary outcomes
Number of Complications
Time frame: Month 3
Rating of Drain Exit Sites
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Bennett W Calder, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-Lock and Suture in people with Surgical Drain, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renea D Jennings, BSN,RN,CCRP (336-716-6709, renea.jennings@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcome Measure Score (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.