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Comparing Outcomes of Secondary Intention Wound Care Methods

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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

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.

Condition or disease Intervention/treatment Phase
Wound Surgical Wound Heal Procedure: Debridement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Debridement
Aggressive vs Minimal 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.
Procedure: Debridement
Aggressive vs Minimal Debridement




Primary Outcome Measures :
  1. Time to healing [ Time Frame: 0-16 weeks ]
    Time to complete healing as determined by one of the study investigators


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of required debridements [ Time Frame: 0-16 weeks ]
    Number of required debridements over the course of healing

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03880331


Contacts
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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

Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Jeffrey B Tiger, MD Lahey Clinic
  Study Documents (Full-Text)

Documents provided by Jeffrey Tiger, Lahey Clinic:
Informed Consent Form  [PDF] March 22, 2019


Publications:

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Responsible Party: Jeffrey Tiger, Principal Investigator, Lahey Clinic
ClinicalTrials.gov Identifier: NCT03880331     History of Changes
Other Study ID Numbers: 20193001
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Tiger, Lahey Clinic:
Secondary intention
Wound care methods
Additional relevant MeSH terms:
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Wounds and Injuries