Trial Outcomes & Findings for Cosmetic Outcome at 4 Months in Hand and Feet Lacerations in Children: Conservative Versus Suture Repair (NCT NCT03321721)

Results Overview

Randomized, parallel group study will compare cosmetic outcome by digital picture by blinded evaluators at 4 months post enrollment. The digital pictures of the laceration repairs were scored using a previously validated Visual Analogue Scale (VAS). The VAS scale is a 100-mm continuous line that is marked at the right end with "best appearance/scar"(score 100), and on the left end with "worst appearance/scar" (score 0).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

4 months

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture-Non Absorbable Patient fulfilling entry criteria will be randomized to the suture arm for repair with non-absorbable (nylon) suture material	Suture-Absorbable Patient fulfilling entry criteria will be randomized to the suture arm for repair with absorbable) suture material
Overall Study STARTED	4	10	12
Overall Study COMPLETED	0	2	1
Overall Study NOT COMPLETED	4	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture-Non Absorbable Patient fulfilling entry criteria will be randomized to the suture arm for repair with non-absorbable (nylon) suture material	Suture-Absorbable Patient fulfilling entry criteria will be randomized to the suture arm for repair with absorbable) suture material
Overall Study Lost to Follow-up	4	8	11

Baseline Characteristics

Ages were not recorded on 4 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conservative n=4 Participants Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture (Absorbable) n=12 Participants Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material	Suture (Non-Absorbable) n=10 Participants Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material	Total n=26 Participants Total of all reporting groups
Age, Continuous	13 years STANDARD_DEVIATION 1 • n=2 Participants • Ages were not recorded on 4 participants	10.3 years STANDARD_DEVIATION 4.61 • n=11 Participants • Ages were not recorded on 4 participants	8.6 years STANDARD_DEVIATION 5.65 • n=9 Participants • Ages were not recorded on 4 participants	9.8 years STANDARD_DEVIATION 5.04 • n=22 Participants • Ages were not recorded on 4 participants
Sex: Female, Male Female	0 Participants n=4 Participants	4 Participants n=12 Participants	3 Participants n=10 Participants	7 Participants n=26 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	8 Participants n=12 Participants	7 Participants n=10 Participants	19 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 Participants n=4 Participants	12 Participants n=12 Participants	10 Participants n=10 Participants	26 Participants n=26 Participants

PRIMARY outcome

Timeframe: 4 months

Population: No participants in the conservative arm/group of the study completed the study protocol. Only 1 participant in the absorbable suture arm/group of the study and 2 participants in the non-absorbable arm/group of the study completed the study protocol.

Randomized, parallel group study will compare cosmetic outcome by digital picture by blinded evaluators at 4 months post enrollment. The digital pictures of the laceration repairs were scored using a previously validated Visual Analogue Scale (VAS). The VAS scale is a 100-mm continuous line that is marked at the right end with "best appearance/scar"(score 100), and on the left end with "worst appearance/scar" (score 0).

Outcome measures

Outcome measures
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture (Absorbable) n=1 Participants Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material	Suture (Non-Absorbable) n=2 Participants Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair	—	60 Score on a scale (100-mm VAS)	100 Score on a scale (100-mm VAS) Standard Deviation 0

SECONDARY outcome

Timeframe: 10-14 days

Population: No participants in the conservative arm/group completed the study. 3 patients in the "absorbable arm" and 4 patients in the "non-absorbable arm" completed the first part and were present for their first follow up.1 of the 3 "absorbable arm" patients completed the entire study and 2 of the 4 "non-absorbable arm" patients completed the entire study.

Wound healing by visual inspection at the first follow up visit. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives. The outcome measure data is reported as the number of participants without the presence of "wound infection" or "wound dehiscence".

Outcome measures

Outcome measures
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture (Absorbable) n=3 Participants Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material	Suture (Non-Absorbable) n=4 Participants Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
Wound Healing in Hand and Feet Lacerations in Children: Conservative vs Suture Repair	—	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10-14 days

Population: No participants in the conservative arm/group completed the study protocol

Infection rate by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.

Outcome measures

Outcome measures
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture (Absorbable) n=3 Participants Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material	Suture (Non-Absorbable) n=4 Participants Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair	—	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10-14 days

Population: No participants in the conservative arm/group completed the study protocol

Rate of wound dehiscence by visual inspection. The wounds will be evaluated for complications that were defined a priori as follows: "wound infection" was one that required systemic antibiotics as determined by the treating attending physician; and "wound dehiscence" as a wound that required the placement of additional sutures or tissue adhesives.

Outcome measures

Outcome measures
Measure	Conservative Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing	Suture (Absorbable) n=3 Participants Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material	Suture (Non-Absorbable) n=4 Participants Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
Cosmetic Outcome of Hand and Feet Laceration in Children : Conservative vs Suture Repair	—	0 Participants	0 Participants

Adverse Events

Conservative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Suture (Absorbable)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Suture (Non-Absorbable)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Trevor L. Tredway

St. Louis University School of Medicine

Phone: 314-577-5630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place