An interventional study of 3M Topical Tissue Adhesive and Histoacryl® Blue Topical Skin Adhesive in Trauma-related Wound, Surgical Incision and Surgical Wound, sponsored by Solventum US LLC. Terminated. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Solventum US LLC · Interventional and Treatment
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's enrollment of 78 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Solventum US LLC is the lead sponsor of 64 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Subject is found to have any of the following before randomization:
Subject has one of the following:
Subject has a wound with any of the following etiologies:
Subject has a wound in any of the following anatomical locations:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3M Topical Tissue Adhesive
Device: 3M Topical Tissue Adhesive
Histoacryl® Blue Topical Skin Adhesive
Device: Histoacryl® Blue Topical Skin Adhesive
Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
Application of control topical tissue adhesive to trauma laceration or surgical incision.
Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
Time frame: 10 days
Tissue Adhesive Remaining
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
Time frame: 10 days
Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive
Time frame: 30 days
Vancouver Scar Scale
Validated tool to assess cosmesis on wounds at 30 days after application of tissue adhesive. Scores range from from 0 (best) to 13 (worst)
Time frame: 30 days
78 Screened, 58 Randomized
| Milestone | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive |
|---|---|---|
| Started | 31 | 27 |
| Treated | 29 | 26 |
| Completed day 10 visit | 26 | 23 |
| Completed day 30 visit | 28 | 23 |
| Completed | 28 | 23 |
| Not completed | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Device deficiency | 1 | 0 |
| Withdrew: Lack of compliance with protocol/investigator withdrawal | 0 | 1 |
| Withdrew: Not treated due to wound class change | 2 | 1 |
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
| participants | Reason Outcome Not Evaluated |
|---|---|
| Apposition of Skin Edges | 0 |
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
| participants | Reason Outcome Not Evaluated |
|---|---|
| Tissue Adhesive Remaining | 0 |
Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive
No measurements were reported for this outcome.
Validated tool to assess cosmesis on wounds at 30 days after application of tissue adhesive. Scores range from from 0 (best) to 13 (worst)
| participants | Reason Outcome Not Evaluated |
|---|---|
| Vancouver Scar Scale | 0 |
Collected over From randomization through end of study participation (Day 30 follow-up visit, ±5 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Topical Tissue Adhesive | 0/29 (0%) | 4/29 (13.8%) | 17/29 (58.6%) |
| Control Topical Tissue Adhesive | 0/26 (0%) | 0/26 (0%) | 5/26 (19.2%) |
| Event | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive |
|---|---|---|
| Abdominal PainGastrointestinal disorders | 2/29 | 0/26 |
| Lung mass (Stage IV lung adenocarcinoma)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/29 | 0/26 |
| Compression fracture of T7 vertebraMusculoskeletal and connective tissue disorders | 1/29 | 0/26 |
| Surgical site infectionInfections and infestations | 1/29 | 0/26 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/29 | 0/26 |
| Hypercarbic Respiratory Failure with Unexplained Metabolic AcidosisRespiratory, thoracic and mediastinal disorders | 1/29 | 0/26 |
| Event | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 9/29 | 3/26 |
| DehiscenceGeneral disorders | 5/29 | 0/26 |
| NauseaGastrointestinal disorders | 3/29 | 1/26 |
| RashSkin and subcutaneous tissue disorders | 2/29 | 1/26 |
| PruritusSkin and subcutaneous tissue disorders | 2/29 | 1/26 |
| OedemaGeneral disorders | 2/29 | 0/26 |
| VomitingGastrointestinal disorders | 2/29 | 0/26 |
| Age, Continuous(years) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Median | 38 (23 to 84) | 38 (22 to 85) | 38 (22 to 85) |
| Sex: Female, Male(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Female | 16 | 14 | 30 |
| Male | 13 | 12 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 14 | 28 |
| Not Hispanic or Latino | 15 | 12 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Black or African American | 3 | 6 | 9 |
| White | 20 | 10 | 30 |
| Other Race | 6 | 10 | 16 |
| BMI(kg/m²) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Median | 31.1 (20.7 to 49.4) | 32.2 (20.4 to 45.8) | 31.8 (20.4 to 49.4) |
| Tobacco Use (Smoking and Non-smoking)(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Never | 21 | 15 | 36 |
| Current | 3 | 6 | 9 |
| Former | 5 | 5 | 10 |
| Fitzpatrick Skin Type(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| I - Type 1 - Very Fair | 7 | 1 | 8 |
| II - Type 2 - Fair | 6 | 4 | 10 |
| III - Type 3 - Medium | 8 | 9 | 17 |
| IV - Type 4 - Olive/ light brown | 5 | 7 | 12 |
| V - Type 5 - Brown | 2 | 2 | 4 |
| VI - Type 6 - Dark brown to black) | 1 | 3 | 4 |
| Laparoscopic Surgery(Participants) | Investigational Topical Tissue Adhesive | Control Topical Tissue Adhesive | Total |
|---|---|---|---|
| Yes | 20 | 21 | 41 |
| No | 8 | 5 | 13 |
| Not Reported | 1 | 0 | 1 |
2 further baseline measures are reported on the registry.
No study locations are listed for this record.
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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