A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
Condition: Wound Closure Technique
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Purpose of the Study This study will seek to compare two absorbable suture materials (PDS and
      chromic gut) in the closure of punch biopsy sites. This information could contribute to cost
      savings and increased convenience for patients.

      Background A punch biopsy is a full thickness skin biopsy performed by Dermatologists to
      diagnose various skin conditions. The incision from the biopsy ranges from 2 - 6mm in width2.
      There have been several recommendations of ways to manage these biopsy sites including the
      use of a non-absorbable suture such as nylon, healing by second intention and the use of an
      absorbable suture such as PDS or Polyglactin 9101,3. The benefit of an absorbable suture over
      a non-absorbable suture is reduced costs to the patient because they will not have pay for a
      suture removal visit. Also, the patients do not have the extra inconvenience of returning to
      the clinic a second time2,3. There has been only one case in the literature comparing an
      absorbable with a non-absorbable suture material in the closure of skin punch biopsy sites2.
      Never, has there been a study comparing two different absorbable suture in this setting. We
      believe there may be a less expensive suture material that would yield the same performance
      as the current ones. If this is the case, this information could benefit the Dermatology
      community in that it would provide a less expensive alternative suture material to close skin
      punch biopsy sites. Therefore, it would cut overall costs related to this routine procedure.

      Chromic gut is an absorbable suture made from natural fibers of sheep or cattle intestine. It
      is one of the first absorbable sutures available and is inexpensive. The difference between
      plain gut and chromic gut is chromic gut is treated with chromic salts which allows it to
      retain its tensile strength longer. The suture integrity lasts 10-14 days (time at when the
      suture begins the absorption process) with complete absorption in 15-60 days. Chromic gut is
      documented to have moderate to high tissue reactivity4,5.

      PDS is an absorbable, monofilament made from synthetic material (polyester). It is a newer,
      more expensive, absorbable suture material. The suture integrity lasts 45-60 days with total
      absorption in 180 days. PDS is documented to have low tissue reactivity and is shown to
      maintain its tensile strength in the presence of a bacterial infection4,5.

      Performance of PDS with chromic gut suture in closing of punch biopsy sites would be compared
      in this study. We hope that the information that we collect could show that the less
      expensive suture (chromic gut) can be safely used in closing skin punch biopsy sites,
      therefore improving the clinical practice of these procedures and saving the health care
      system money.

      Number of Subjects Up to 100 subjects are anticipated in this project. Inclusion/Exclusion
      Criteria Inclusion Criteria

      In order for patients to participate in this study, they must:

        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

      Patients may not participate in this study if they:

        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 Vulnerable Subjects Elderly
           subjects will be included in this study. However, these subjects will not be coerced in
           any way to participate. As with all other subjects, the investigator will explain the
           purpose of the research and the nature and duration of the procedures to elderly
           subjects. The investigator will then explain the risk of a breach of confidentiality,
           the possible societal benefits associated with the study, and the right of subjects to
           withdraw consent at any time without penalty. The investigator will ask the subject to
           confirm that they fully understand all of these issues, and subjects will be asked if
           they have any questions about the research. Before data collection can occur, the
           subject's questions concerning the study must be answered to his or her satisfaction.

      Method of Subject Identification and Recruitment Patients age 18 and over who meet the
      study's inclusion criteria will be asked during their office visit of their willingness to
      participate in a study that compares two absorbable suture materials (PDS and chromic gut) in
      the closure of punch biopsy sites. Patients who choose to participate must sign a consent
      form after the study protocol has been explained and is fully understood. The dermatologist
      will perform a punch biopsy and will close the skin with either the PDS or chromic gut
      suture. The patients will be randomized into either Group A that will receive PDS suture or
      Group B that will receive chromic gut suture. A nurse will place patients into groups A and B
      based on whether they are an even or an odd patient.

      Methods and Procedures Applied to Human Subjects During their office visit, patients over the
      age of 18 who meet the inclusion criteria and do not meet the exclusion criteria will be
      invited to participate in the study. Patients who choose to participate will be given a
      verbal explanation of the study protocol by an investigator. A punch biopsy will be performed
      and each site will be closed with one simple percutaneous suture using a P-3 needle and
      aseptic technique. The type of suture received by the patient will be randomized. Group A
      will receive PDS suture and Group B will receive chromic gut suture. The wounds will be
      dressed with bacitracin and an adhesive bandage. The sites will be treated with twice daily
      bacitracin and bandage changes by the patient. After one weeks time, the patient will return
      to clinic and their dermatologist will evaluate the biopsy site for redness, wound infection,
      wound dehiscence, and scar hypertrophy. The patients will be given a questionnaire evaluating
      their satisfaction with the cosmetic outcome and any pain caused by the suture. 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 in one week and the same evaluation will be performed by their
      Dermatologist as well as given the same questionnaire. Lastly, the patients will return for
      their fourth total visit to once again be given the same evaluation by their Dermatologist as
      well as given the same questionnaire.

      Setting and Mode of Administering Suture Materials, Evaluation and Questionaire

      Data collection will take place in the following location:

      • Face and Skin Center Township at Colony Park 201 Northlake Avenue, Suite 211 Ridgeland, MS
      39157

      Each participant will be educated on study protocol before data collection begins. The
      Dermatologist will perform the biopsy and place the suture. The patients will receive
      bacitracin oitment applied to the biopsy site and an adhesive bandage will be administered.
      Patients will be given a follow-up appointment in one week. Patients will return to clinic in
      one week. Their Dermatologist that performed the procedure will evaluate the biopsy site and
      the patient will be given a questionnaire to complete and asked to report if and when if
      applicable the suture fell out. This process will continue every week for one month.

      Data Collection, Storage, and Confidentiality Data will be collected by study personnel and
      will be associated with the patient's name. Study personnel will interview subjects in order
      to complete a standardized questionnaire. Patients' records will be kept in locked filing
      cabinets at the data collection site. All digital patient information will be password
      protected. Access to the data will be limited to only the investigators. Data will be kept
      for six years following completion of the study, and will then be shredded and destroyed.

      Potential Risks and Discomforts There are no financial risks associated with this study.
      There is, however, a risk of breached confidentiality. Although a breach of confidentiality
      would not be reversible, it would cause minimal harm to the subjects, as the type of suture
      the patient received is not a sensitive medical or legal problem. Protocol to minimize risks
      associated with this study will ensure a low probability that subjects will be harmed in any
      way. Patients' records will be kept in locked filing cabinets at the data collection site.
      All digital patient information will be password protected. Access to the data will be
      limited to only the investigators. Data will be kept for two years following completion of
      the study, and will then be shredded and destroyed.

      Risk Classification The overall risk classification of this research is minimal. Minimizing
      Risks Patients' records will be kept in the principal investigator's medical office in a
      locked filing cabinet. All digital patient information will be password protected. Access to
      the data will be limited to only the investigators. Data will be kept for two years following
      completion of the study, and will then be shredded and destroyed.

      Potential Benefits There is no direct benefit to patients participating in this study.
      Societal benefits can be expected from this research, which provides information that could
      contribute to cost-saving strategies and quality of life enhancements associated with skin
      punch biopsies.

      Risk/Benefit Ratio Payment for Participation Subjects will not be provided with financial
      compensation for their participation in this study.

      Financial Obligations of the Subjects Subjects will not incur any financial obligations as a
      result of participating in this study except the cost of the punch biopsy procedure. They
      will not be charged for the follow-up visits. The cost of the punch biopsy procedure is not
      increased because of their participation.

      Emergency Care and Compensation for Research-Related Injury Not Applicable Capacity to
      Consent All adult subjects involved in this study, which involves minimal risk, will have the
      capacity to consent.

      Personnel Inviting Participants

      The following research personnel will be authorized to describe the research to subjects and
      to invite their participation:

        -  Robert T. Brodell, M.D.-Principal Investigator

        -  Nancye K. McCowan, M.D. -

        -  Allison Jones-Student The investigator will begin by confirming that the subject meets
           all inclusion criteria and does not meet any exclusion criteria. The subject will then
           be asked during their office visit if they would be interested in participating in a
           study that compares two absorbable suture materials (PDS and chromic gut) in the closure
           of punch biopsy sites. The investigator will explain the purpose of the research and the
           nature and duration of the procedures to the subject. The investigator will then explain
           the risk of a breach of confidentiality, the possible societal benefits associated with
           the study, and the right of subjects to withdraw consent at any time without penalty.
           The investigator will ask the subject to confirm that they fully understand all of these
           issues, and subjects will be asked if they have any questions about the research. Before
           data collection can occur, the subject's questions concerning the study must be answered
           to his or her satisfaction.

      Seth Bendo, M.D. has participated in conceiving this study and planning its execution, and he
      will help edit the publication that results from this work. He will not be asking his
      patients to participate in the study.

      Process of Consent The consent process will take place during the subject's office visit. The
      investigator will ask the subject if they are interested in participating in a study that
      compares two absorbable suture materials (PDS and chromic gut) in the closure of punch biopsy
      sites.

      Comprehension of the Information Provided The investigator will explain the purpose of the
      research and the nature and duration of the procedures to the subject. The investigator will
      then explain the risk of a breach of confidentiality, the possible societal benefits
      associated with the study, and the right of subjects to withdraw consent at any time without
      penalty. The investigator will ask the subject to confirm that they fully understand all of
      these issues, and subjects will be asked if they have any questions about the research.
      Before data collection can occur, the subject's questions concerning the study must be
      answered to his or her satisfaction.

      Information Withheld From Subjects There will be no information withheld from potential or
      participating subjects regarding the research purpose and design.

      Consent/Assent Forms Adult consent forms will be used in this study. Informed Consent
      Personal identifiers will be recorded in this study. A copy of the consent form to be used is
      attached.
    

Intervention name(s): Polyglactin 910 sterile synthetic absorbable suture (Ethicon); Chromic Gut Sterile absorbable Suture (Ethicon)
Intervention type(s): Device; Device
Intervention description(s): Half of punch biopsy wounds are closed with each absorbablesuture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment