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A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722994
Recruitment Status : Completed
First Posted : November 7, 2012
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Brodell, University of Mississippi Medical Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Length of Time Till Absorbable Suture Fall Out [ Time Frame: 3 weeks ]
    The time post placement when the suture fell out.

  2. Presence of Infection [ Time Frame: 1 week ]
    Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).

  3. Presence of Infection [ Time Frame: 3 weeks ]
    Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be age 18 or older
  2. Having a punch biopsy procedure performed for benign reasons
  3. Biopsy site is between the shoulders and ankles

Exclusion Criteria:

  1. Having a punch biopsy procedure performed for a suspicious cancerous lesion including basal and squamous cell carcinoma and melanoma
  2. Biopsy site is on the face, palms, soles or groin area

Information from the National Library of Medicine

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


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: Robert T Brodell, MD University of Mississippi Medical Center

Publications of Results:
Other Publications:
2. Habif TP. Clinical Dermatology: A Color Guide to Diagnosis and Therapy, 5th ed. Philadelphia, Pa: Mosby; 2010: 1006.
4. Lammers, RL. Methods of Wound Closure. In Roberts JR, Hedges JR. Clinical Procedures in Emergency Medicine, 5th ed. Philadelphia, PA: Saunders Elsevier. 2009:592-633

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Responsible Party: Robert Brodell, Professor and Chief, Division of Dermatology, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01722994    
Other Study ID Numbers: 2012-0180
First Posted: November 7, 2012    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016
Last Verified: February 2016