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This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.
Study Design
This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.
Methods
Inclusion Criteria All adult patients undergoing an elective laparoscopic or robotic abdominal surgery with the Minimally Invasive Surgeons of Texas (MIST) either at Texas Medical Center or Sugar Land will be eligible.
Exclusion criteria
Treatment Groups Eligible patients will be approached by research staff either in clinic or in pre-operative holding for trial enrollment. Each patient will serve as their own control. Enrolled patients will have both surgical glue types used, one on each half of their abdomen. The side for each glue will be randomly assigned by the day of the month. On odd days, 2-Octylcyanoacrylate will go on the patient's left abdomen. On even days, 2-Octylcyanoacrylate will go on the patient's right abdomen. If there is an odd number of incisions, the extra incision will be included on the patient's left.
All incisions will be closed with Monocryl. Closed incisions will be covered with skin glue.
Outcome The primary outcome of this trial will be the proportion of patients with contact dermatitis within 6 weeks post-operative. A trained surgical clinician blinded to the treatment arms will collect outcomes at all follow up clinic visits in the first 6 weeks post-operative. Any skin reaction will be documented with photographs.
Secondary outcome will include the diameter of erythema around any skin reaction, or any wound dehiscence or surgical site infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermabond (2-Octylcyanoacrylate) | Active Comparator | Dermabond over incisions |
|
| Swiftset (N-butyl-2-cyanoacrylate) | Active Comparator | Swiftset over incisions |
|
| Liquiband (2-Octylcyanoacrylate) | Active Comparator | Liquiband over incisions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabond (2-Octylcyanoacrylate) | Device | Incisions on left will have one glue and on right will have the other glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Develop Contact Dermatitis | Contact Dermatitis is defined as erythema or rash around incisions | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diameter of Erythema | mean diameter of erythema around incisions for those with contact dermatitis | 6 weeks |
| Number of Participants With Wound Dehiscence | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann | Houston | Texas | 77030 | United States |
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The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, no participants were enrolled in this arm. A total of 180 participants were enrolled. Each participant served as their own control. For each participant two surgical glue types were used, one on each half of their abdomen
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| ID | Title | Description |
|---|---|---|
| FG000 | Dermabond (2-Octylcyanoacrylate) | Dermabond over incisions Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue |
| FG001 | Swiftset (N-butyl-2-cyanoacrylate) | Swiftset over incisions Swiftset (N-butyl-2-cyanoacrylate): Incisions on left will have one glue and on right will have the other glue |
| FG002 | Liquiband (2-Octylcyanoacrylate) | Liquiband over incisions Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants served as their own control in this split-person design, with each receiving both surgical glue types applied to opposite sides of the abdomen. Baseline characteristics are reported at the participant level using a single group ("All Participants") to avoid double counting.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received both interventions. One surgical glue (Dermabond [2-Octylcyanoacrylate]) was applied to incisions on one side of the abdomen and the other glue (Liquiband [2-Octylcyanoacrylate]) was applied to the opposite side. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Develop Contact Dermatitis | Contact Dermatitis is defined as erythema or rash around incisions | Posted | Count of Participants | Participants | 6 weeks |
|
Up to 6 weeks
Adverse Events are only reported for the two arms participants were enrolled in. The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, zero participants were enrolled in this arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dermabond (2-Octylcyanoacrylate) | Dermabond over incisions Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Holihan, MD | The University of Texas Health Science Center at Houston | 7135007245 | julie.l.holihan@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 | Mar 26, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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Each subject will have both glue types and serve as their own control
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Outcome assessor does not know which glue was used
| Swiftset (N-butyl-2-cyanoacrylate) | Device | Incisions on left will have one glue and on right will have the other glue |
|
| Liquiband (2-Octylcyanoacrylate) | Device | Incisions on left will have one glue and on right will have the other glue |
|
| Number of Participants With Surgical Site Infection | 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Diameter of Erythema | mean diameter of erythema around incisions for those with contact dermatitis | This outcome measure was pre-specified in the protocol, however no data were collected for this measure because the assessment was not performed. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | 6 weeks |
|
|
| Secondary | Number of Participants With Wound Dehiscence | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| 21 |
| 180 |
| EG001 | Liquiband (2-Octylcyanoacrylate) | Liquiband over incisions Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue | 0 | 180 | 0 | 180 | 18 | 180 |
| EG002 | Swiftset (N-butyl-2-cyanoacrylate) | Swiftset over incisions Swiftset (N-butyl-2-cyanoacrylate): Incisions on left will have one glue and on right will have the other glue | 0 | 0 | 0 | 0 | 0 | 0 |
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