Trial Outcomes & Findings for 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions (NCT NCT06217081)
NCT ID: NCT06217081
Last Updated: 2026-07-27
Results Overview
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
Recruitment status
TERMINATED
Target enrollment
78 participants
Primary outcome timeframe
10 days
Results posted on
2026-07-27
Participant Flow
78 Screened, 58 Randomized
After randomization, 3 were not treated due to wound class change, leaving 55 treated.
Participant milestones
| Measure |
Investigational Topical Tissue Adhesive
3M Topical Tissue Adhesive
3M Topical Tissue Adhesive: Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
|
Control Topical Tissue Adhesive
Histoacryl® Blue Topical Skin Adhesive
Histoacryl® Blue Topical Skin Adhesive: Application of control topical tissue adhesive to trauma laceration or surgical incision.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
|
Overall Study
Treated
|
29
|
26
|
|
Overall Study
Completed Day 10 Visit
|
26
|
23
|
|
Overall Study
Completed Day 30 Visit
|
28
|
23
|
|
Overall Study
COMPLETED
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Investigational Topical Tissue Adhesive
3M Topical Tissue Adhesive
3M Topical Tissue Adhesive: Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
|
Control Topical Tissue Adhesive
Histoacryl® Blue Topical Skin Adhesive
Histoacryl® Blue Topical Skin Adhesive: Application of control topical tissue adhesive to trauma laceration or surgical incision.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Device Deficiency
|
1
|
0
|
|
Overall Study
Lack of compliance with protocol/investigator withdrawal
|
0
|
1
|
|
Overall Study
Not treated due to wound class change
|
2
|
1
|
Baseline Characteristics
3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions
Baseline characteristics by cohort
| Measure |
Investigational Topical Tissue Adhesive
n=29 Participants
3M Topical Tissue Adhesive
3M Topical Tissue Adhesive: Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
|
Control Topical Tissue Adhesive
n=26 Participants
Histoacryl® Blue Topical Skin Adhesive
Histoacryl® Blue Topical Skin Adhesive: Application of control topical tissue adhesive to trauma laceration or surgical incision.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=9 Participants
|
38 years
n=27 Participants
|
38 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
6 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
BMI
|
31.1 kg/m²
n=9 Participants
|
32.2 kg/m²
n=27 Participants
|
31.8 kg/m²
n=267 Participants
|
|
Tobacco Use (Smoking and Non-smoking)
Never
|
21 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Tobacco Use (Smoking and Non-smoking)
Current
|
3 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Tobacco Use (Smoking and Non-smoking)
Former
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
I - Type 1 - Very Fair
|
7 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
II - Type 2 - Fair
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
III - Type 3 - Medium
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
IV - Type 4 - Olive/ light brown
|
5 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
V - Type 5 - Brown
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Fitzpatrick Skin Type
VI - Type 6 - Dark brown to black)
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Laparoscopic Surgery
Yes
|
20 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
41 Participants
n=267 Participants
|
|
Laparoscopic Surgery
No
|
8 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Laparoscopic Surgery
Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Hernia Surgery
Yes
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Hernia Surgery
No
|
21 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Hernia Surgery
No response
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Length of wound
|
20.0 Millimeters (mm)
n=9 Participants
|
22.5 Millimeters (mm)
n=27 Participants
|
20.5 Millimeters (mm)
n=267 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Outcome data were not collected/analyzed because the study was terminated early by the Sponsor due to safety concerns, including the frequency of adverse events. Following early termination, wound images required for independent assessor evaluation of endpoints were not provided, and the prespecified efficacy/performance analyses were not conducted. Therefore, outcome analyses were not performed, and the study results are limited to safety endpoints only.
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
Outcome measures
| Measure |
Reason Outcome Not Evaluated
Study was terminated early; no evaluation of efficacy or performance was performed.
|
|---|---|
|
Apposition of Skin Edges
|
0 participants
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome data were not collected/analyzed because the study was terminated early by the Sponsor due to safety concerns, including the frequency of adverse events. Following early termination, wound images required for independent assessor evaluation of endpoints were not provided, and the prespecified efficacy/performance analyses were not conducted. Therefore, outcome analyses were not performed, and the study results are limited to safety endpoints only.
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
Outcome measures
| Measure |
Reason Outcome Not Evaluated
Study was terminated early; no evaluation of efficacy or performance was performed.
|
|---|---|
|
Tissue Adhesive Remaining
|
0 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Outcome data were not collected/analyzed because the study was terminated early by the Sponsor due to safety concerns, including the frequency of adverse events. Following early termination, wound images required for independent assessor evaluation of endpoints were not provided, and the prespecified efficacy/performance analyses were not conducted. Therefore, outcome analyses were not performed, and the study results are limited to safety endpoints only.
Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: Outcome data were not collected/analyzed because the study was terminated early by the Sponsor due to safety concerns, including the frequency of adverse events. Following early termination, wound images required for independent assessor evaluation of endpoints were not provided, and the prespecified efficacy/performance analyses were not conducted. Therefore, outcome analyses were not performed, and the study results are limited to safety endpoints only.
Validated tool to assess cosmesis on wounds at 30 days after application of tissue adhesive. Scores range from from 0 (best) to 13 (worst)
Outcome measures
| Measure |
Reason Outcome Not Evaluated
Study was terminated early; no evaluation of efficacy or performance was performed.
|
|---|---|
|
Vancouver Scar Scale
|
0 participants
|
Adverse Events
Investigational Topical Tissue Adhesive
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Control Topical Tissue Adhesive
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Topical Tissue Adhesive
n=29 participants at risk
3M Topical Tissue Adhesive
3M Topical Tissue Adhesive: Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
|
Control Topical Tissue Adhesive
n=26 participants at risk
Histoacryl® Blue Topical Skin Adhesive
Histoacryl® Blue Topical Skin Adhesive: Application of control topical tissue adhesive to trauma laceration or surgical incision.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
2/29 • Number of events 2 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung mass (Stage IV lung adenocarcinoma)
|
3.4%
1/29 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Musculoskeletal and connective tissue disorders
Compression fracture of T7 vertebra
|
3.4%
1/29 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Infections and infestations
Surgical site infection
|
3.4%
1/29 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Respiratory, thoracic and mediastinal disorders
Hypercarbic Respiratory Failure with Unexplained Metabolic Acidosis
|
3.4%
1/29 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
Other adverse events
| Measure |
Investigational Topical Tissue Adhesive
n=29 participants at risk
3M Topical Tissue Adhesive
3M Topical Tissue Adhesive: Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
|
Control Topical Tissue Adhesive
n=26 participants at risk
Histoacryl® Blue Topical Skin Adhesive
Histoacryl® Blue Topical Skin Adhesive: Application of control topical tissue adhesive to trauma laceration or surgical incision.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
31.0%
9/29 • Number of events 16 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
11.5%
3/26 • Number of events 5 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
2/29 • Number of events 7 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
3.8%
1/26 • Number of events 8 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29 • Number of events 7 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
3.8%
1/26 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
General disorders
Dehiscence
|
17.2%
5/29 • Number of events 7 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
General disorders
Oedema
|
6.9%
2/29 • Number of events 5 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
0.00%
0/26 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
3.8%
1/26 • Number of events 1 • From randomization through end of study participation (Day 30 follow-up visit, ±5 days)
Adverse events were assessed systematically at each scheduled and unscheduled study visit through active subject questioning, clinical evaluation, and review of medical records. Events were recorded in the eCRF and evaluated for seriousness, severity, relatedness, and outcome
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place