Dermatitis, Contact
Conditions
Keywords
GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS
Brief summary
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.
Detailed description
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 1. Patients unlikely to follow-up (live out of state, unable to be reached by phone or email) 2. Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate. 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.
Interventions
DEVICEDermabond (2-Octylcyanoacrylate)
Incisions on left will have one glue and on right will have the other glue
DEVICESwiftset (N-butyl-2-cyanoacrylate)
Incisions on left will have one glue and on right will have the other glue
DEVICELiquiband (2-Octylcyanoacrylate)
Incisions on left will have one glue and on right will have the other glue
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor does not know which glue was used
Intervention model description
Each subject will have both glue types and serve as their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or older * undergoing an elective laparoscopic or robotic abdominal surgery
Exclusion criteria
* Patients unlikely to follow-up (live out of state, unable to be reached by phone or email) * Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Contact Dermatitis | 6 weeks | Contact Dermatitis is defined as erythema or rash around incisions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diameter of Erythema | 6 weeks | mean diameter of erythema around incisions for those with contact dermatitis |
| Number of Participants With Wound Dehiscence | 6 weeks | — |
| Number of Participants With Surgical Site Infection | 6 weeks | — |
Countries
United States
Participant flow
Pre-assignment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47 years |
| Region of Enrollment United States | 180 participants |
| Sex: Female, Male Female | 131 Participants |
| Sex: Female, Male Male | 49 Participants |
| Type of Surgery Cholecystectomy | 3 Participants |
| Type of Surgery Duodenal Switch | 12 Participants |
| Type of Surgery Gastric Bypass | 56 Participants |
| Type of Surgery Hiatal Hernia Repair | 9 Participants |
| Type of Surgery Inguinal Hernia Repair | 17 Participants |
| Type of Surgery Revisional Bariatric | 35 Participants |
| Type of Surgery Sleeve Gastrectomy | 40 Participants |
| Type of Surgery Small Bowl Resection | 2 Participants |
| Type of Surgery Ventral Hernia Repair | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 180 | 0 / 0 |
| other Total, other adverse events | 21 / 180 | 18 / 180 | 0 / 0 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 | 0 / 0 |
Outcome results
None listed