Trial Outcomes & Findings for A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites (NCT NCT01722994)
NCT ID: NCT01722994
Last Updated: 2016-03-02
Results Overview
All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).
COMPLETED
PHASE4
97 participants
1 week
2016-03-02
Participant Flow
Participant milestones
| Measure |
Group 1 Punch Biopsy Wound Using Chromic Gut Suture
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
COMPLETED
|
24
|
31
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
Reasons for withdrawal
| Measure |
Group 1 Punch Biopsy Wound Using Chromic Gut Suture
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Overall Study
Missing data
|
25
|
17
|
Baseline Characteristics
A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
Baseline characteristics by cohort
| Measure |
Group 1 Punch Biopsy Wound Using Chromic Gut Suture
n=49 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture
n=48 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years and older
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not collected
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.
All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).
Outcome measures
| Measure |
Group 1 Punch Biopsy Wound
n=24 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound
n=31 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Presence of Scarring
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.
All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).
Outcome measures
| Measure |
Group 1 Punch Biopsy Wound
n=24 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound
n=31 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Presence of Scarring
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.
The time post placement when the suture fell out.
Outcome measures
| Measure |
Group 1 Punch Biopsy Wound
n=24 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound
n=31 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Length of Time Till Absorbable Suture Fall Out
|
15.7 Days
Standard Deviation 6.9
|
20.2 Days
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.
Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).
Outcome measures
| Measure |
Group 1 Punch Biopsy Wound
n=24 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound
n=31 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Presence of Infection
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.
Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).
Outcome measures
| Measure |
Group 1 Punch Biopsy Wound
n=24 Participants
One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)
|
Group 2 Punch Biopsy Wound
n=31 Participants
This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture
|
|---|---|---|
|
Presence of Infection
|
1 participants
|
0 participants
|
Adverse Events
Group 1 Punch Biopsy Wound
Group 2 Punch Biopsy Wound
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Brodell
University of Mississippi Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place