Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Outcomes of Secondary Intention Wound Care Methods

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880331
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Tiger, Lahey Clinic

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date August 21, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Time to healing [ Time Frame: 0-16 weeks ]
Time to complete healing as determined by one of the study investigators
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03880331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ) [ Time Frame: 0-16 weeks. NOTE: The PSAQ will be completed by the patient once their wound is determined to be completely healed by the study investigators; usually between 6-8 weeks. ]
    As assessed by the Patient Scar Assessment Questionnaire (PSAQ), a validated questionnaire used standardly in Dermatology for assessing patient-based outcome measures of scarring. It consists of 5 subscales: appearance, symptoms consciousness, satisfaction with appearance and satisfaction with symptoms. Each subscale consists of a set of items with 4-point categorical responses, scoring 1 to 4 points (with 1 point assigned to the most favorable category and 4 assigned to the least favorable). It has been demonstrated to be a reliable and valid measure of patients' perception of scarring. See reference #12 in reference list for more information.
  • Cosmetic Appearance [ Time Frame: 0-16 weeks. NOTE: A photograph of the the patient's final healed wound will be evaluated by a blinded investigator after the wound is determined to be completely healed by the study investigators; usually between 6-8 weeks ]
    As assessed by the Visual Analog Scale, a validated image-based scale, that uses photographs for evaluation in 5 dimensions (pigmentation, vascularity, acceptability, observer comfort, and contour). "Observer comfort" measures the observer's "comfort level" when viewing the wound. The benefit of using this scale for the purposes of the study is because it is a photograph-based scale which can be evaluated later by a blinded physician rather than in the clinic at the time of the visit. The observer places a mark along a continuous line that measures 10cm long, and then that is measured from left to right and a corresponding score is given corresponding to that length (between 0 and 10). The individual scores are tallied to obtain a single overall score ranging from "poor" to "excellent." See reference #13 in reference list for more information.
  • Number of required debridements [ Time Frame: 0-16 weeks ]
    Number of required debridements over the course of healing
  • Number of treatment failures [ Time Frame: Through study completion, an average of 6-8 weeks ]
    Number of wounds that do not heal by 16 weeks
  • Complications [ Time Frame: 0-16 weeks ]
    Including degree of pain (on a scale of 0-10), number of episodes of bleeding, number of infection, and incidence of tumor recurrence
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Outcomes of Secondary Intention Wound Care Methods
Official Title  ICMJE Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Brief Summary This is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.
Detailed Description

Secondary intention is an established method of allowing post-surgical defects to heal. Previous studies have shown a positive association between the frequency of debridement and healing rates in chronic wounds. However, the effect of debridement on acute, post-surgical wounds is not well-described in the literature.

This randomized controlled trial is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:
Blinded investigator will assess photographs of completely healed wounds
Primary Purpose: Treatment
Condition  ICMJE
  • Wound Surgical
  • Wound Heal
Intervention  ICMJE Procedure: Debridement
Aggressive vs Minimal Debridement
Study Arms  ICMJE
  • Active Comparator: Aggressive Debridement
    Aggressive and frequent debridement of fibrin and crust from the wound base down to pinpoint bleeding, both by the patient as part of daily wound care at home, and also by the clinician (either physician or experienced dermatologic surgery nurse) during follow-up visits. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return weekly until healed. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.
    Intervention: Procedure: Debridement
  • Active Comparator: Minimal Debridement
    No debridement of fibrin by the patient or the clinician. Exceptions include debridement of dried crust or eschar. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return every two weeks until healed. In between visits at weekly intervals, the patient will be contacted by phone to determine if healing has occurred in between clinic visits11. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.
    Intervention: Procedure: Debridement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Dermatology patients at Lahey Clinic:
  2. who have undergone Mohs surgery or excision
  3. who are older than 18 years
  4. who are able to give consent
  5. who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities
  6. who are willing and able to return to clinic in Peabody, MA, for all wound care visits

Exclusion Criteria:

  1. Unable to consent (due to language barrier or mental status)
  2. Unable to perform daily wound care
  3. Unwilling or unable to return for follow-up
  4. Have baseline venous stasis or pitting edema of the affected limb
  5. Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jeffrey B Tiger, MD 781-744-8348 jeffrey.b.tiger@lahey.org
Contact: Michelle P Curran, RN 781-744-8348 michelle.p.curran@lahey.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880331
Other Study ID Numbers  ICMJE 20193001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Final results will be shared with another investigator who will not be participating in the clinical trial but will author the paper. All individual participant data will be de-identified before sharing with this investigator.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available once the final patient has finished the study and the data has been compiled and de-identified. It will be available until the paper is accepted for publication.
Access Criteria: Investigator will have access to the results as needed to author the paper.
Responsible Party Jeffrey Tiger, Lahey Clinic
Study Sponsor  ICMJE Lahey Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey B Tiger, MD Lahey Clinic
PRS Account Lahey Clinic
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP