A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
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|ClinicalTrials.gov Identifier: NCT01722994|
Recruitment Status : Completed
First Posted : November 7, 2012
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch biopsy sites. The reason these are often preferred is because patients do not have to pay for another visit to get the suture material removed. Also patients are not inconvenienced into returning to the office for suture removal1. However, the absorbable suture material currently used by most Dermatologists is very expensive.
In order to evaluate ways to reduce costs for patients, we will compare a less expensive suture material (chromic gut) with one of the absorbable suture materials currently used in clinical practice (PDS).
Patients who are eligible and choose to participate in the study will undergo a punch biopsy and a suture will be used to close the skin. The type of suture received by the patient will be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive chromic gut suture.
After one weeks time, the patient will return to clinic and their dermatologist will evaluate the biopsy site for redness, wound infection, wound opening, and scar formation. The patients will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any pain caused by the suture materials. If the suture came out before the visit, the patient will be asked to report on what day the suture fell out. The patients will return two more times over the next two weeks to receive the same questionnaire and evaluation by their dermatologist.
|Condition or disease||Intervention/treatment||Phase|
|Wound Closure Technique||Device: Polyglactin 910 sterile synthetic absorbable suture (Ethicon) Device: Chromic Gut Sterile absorbable Suture (Ethicon)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Group 1 Punch Biopsy Wound with chromic gut suture
One of two absorbable sutures is used to close punch wounds.
Device: Chromic Gut Sterile absorbable Suture (Ethicon)
Experimental: Group 2 Punch Biopsy Wound with PDS
This is one of two absorbable sutures used to close punch biopsy wounds.
Device: Polyglactin 910 sterile synthetic absorbable suture (Ethicon)
Half of punch biopsy wounds are closed with each absorbablesuture
- Presence of Scarring [ Time Frame: 1 week ]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).
- Presence of Scarring [ Time Frame: 3 weeks ]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).
- Length of Time Till Absorbable Suture Fall Out [ Time Frame: 3 weeks ]The time post placement when the suture fell out.
- Presence of Infection [ Time Frame: 1 week ]Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).
- Presence of Infection [ Time Frame: 3 weeks ]Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722994
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Robert T Brodell, MD||University of Mississippi Medical Center|