Laceration, Surgical Incision, Surgical Wound, Trauma-related Wound
Conditions
Brief summary
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive with follow-up visits at 10 days and 30 days after application of tissue adhesive.
Detailed description
This is a multicenter, prospective, open-label, randomized, non-inferiority study that will include 452 randomized Subjects requiring closure of superficial lacerations, clean traumatic lacerations, low-tension incisions, or surgical incisions from minimally invasive surgeries. The study will enroll Subjects from up to 10 sites in the USA. Subjects will be seen during Screening (no more than 10 days before application of tissue adhesive), on the day in which skin edges of wound(s) are reapproximated and tissue adhesive is applied (Day 0), 10 days after application of the tissue adhesive, and 30 days after application of the tissue adhesive.
Interventions
DEVICE3M Topical Tissue Adhesive
Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
DEVICEHistoacryl® Blue Topical Skin Adhesive
Application of control topical tissue adhesive to trauma laceration or surgical incision.
Sponsors
Solventum US LLC
United States Department of Defense
The University of Texas Health Science Center at San Antonio
3M
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is at least 22 years of age on the date of informed consent * Subject or Subject's legally authorized representative can provide informed consent * Subject is willing and able to attend all scheduled study visits and abide by all study restrictions * Subject has a single laceration that is ≤ 100 mm (10.0 cm) in length or up to 4 surgical incision(s), each ≤ 100 mm (10.0 cm) in length, defined as Class I or Class II wound(s), in which the use of a tissue adhesive (in combination with but not replacing deep dermal sutures, if applicable) is appropriate, including the following: * surgical incision from a minimally invasive surgery * low tension incision * superficial laceration * clean, traumatic laceration with edges that can be easily approximated
Exclusion criteria
* Subject has a positive pregnancy test within 48 hours prior to randomization at Day 0 or is lactating prior to randomization at Day 0 * Subject is found to have any of the following before randomization: * a known peripheral vascular disease * a history of hypertrophic scarring and/or keloids * any Class III or Class IV wounds * uncontrolled diabetes mellitus (DM), defined as HbA1C ≥ 10% within 90 days before screening. If HbA1C data is unavailable or the Subject presents in an emergency situation, uncontrolled DM will be defined as blood glucose ≥ 250 mg/dL * a known blood clotting disorder * immunocompromised * a known systemic or local bacterial, viral, or fungal infection * critical injury * condition(s) that in the opinion of the Investigator will impact study results (eg, hemophilia or autoimmune disorder) or the ability of the Subject to remain compliant with study procedures, study restrictions, and/or visits * Subject has a known hypersensitivity or allergy to any of the components of study products (eg, polyoxamides or cyanoacrylates) * Subject is concurrently participating in or was enrolled in another interventional clinical study within 30 days of randomization * Subject has a laceration or incision that is \> 100 mm (10 cm) in length * Subject has any incision that is within 5 cm of any adjacent incision * Subject has one of the following: * a "burst" or stellate laceration * wound with exposed bone * wound with suspected skin edge ischemia due to extensive undermining * wound requiring drain(s) * wound requiring a conventional closure method (eg, subcuticular/intradermal suture, staples, adhesive strips) OR subcuticular stitch placement for enhanced wound support (ie, to further minimize tension) * Subject has a wound with any of the following etiologies: * human or animal bite * prolonged pressure (ie, decubitus) * Subject has a wound in any of the following anatomical locations: * on mucosal surfaces or across mucocutaneous junctions (eg, oral cavity, lips) * in or around the eyes * an anatomical area that is under tension or over a joint * on an area that may be regularly exposed to body fluids or with dense natural hair present (eg, scalp)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apposition of Skin Edges | 10 days | Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Adhesive Remaining | 10 days | Percentage (%) of the sum of the subject's wound length(s), in relation to the sum of the original incision/laceration length(s), with tissue adhesive remaining at 10 days after application of tissue adhesive |
| Apposition of Skin Edges | 30 days | Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive |
Participant flow
Recruitment details
78 Screened, 58 Randomized
Pre-assignment details
After randomization, 3 were not treated due to wound class change, leaving 55 treated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38 years |
| BMI | 32.2 kg/m² |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type III - Type 3 - Medium | 8 Participants |
| Fitzpatrick Skin Type II - Type 2 - Fair | 10 Participants |
| Fitzpatrick Skin Type I - Type 1 - Very Fair | 7 Participants |
| Fitzpatrick Skin Type IV - Type 4 - Olive/ light brown | 12 Participants |
| Fitzpatrick Skin Type VI - Type 6 - Dark brown to black) | 3 Participants |
| Fitzpatrick Skin Type V - Type 5 - Brown | 2 Participants |
| Hernia Surgery No | 18 Participants |
| Hernia Surgery No response | 0 Participants |
| Hernia Surgery Yes | 8 Participants |
| Laparoscopic Surgery No | 5 Participants |
| Laparoscopic Surgery Not Reported | 1 Participants |
| Laparoscopic Surgery Yes | 41 Participants |
| Length of wound | 20.0 Millimeters (mm) |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Other Race | 16 Participants |
| Race/Ethnicity, Customized White | 30 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 12 Participants |
| Tobacco Use (Smoking and Non-smoking) Current | 3 Participants |
| Tobacco Use (Smoking and Non-smoking) Former | 10 Participants |
| Tobacco Use (Smoking and Non-smoking) Never | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 26 |
| other Total, other adverse events | 17 / 29 | 5 / 26 |
| serious Total, serious adverse events | 4 / 29 | 0 / 26 |
Outcome results
None listed