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Completed

NCT Number: NCT03880331

Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods

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.

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Key information

Conditions

Wound Surgical Surgical Wound Wound Heal Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Medical Center Peabody

Peabody, Massachusetts, 01960, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to consent (due to language barrier or mental status)
  • Unable to perform daily wound care
  • Unwilling or unable to return for follow-up
  • Have baseline venous stasis or pitting edema of the affected limb
  • Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.

Treatment and study plan

Debridement

Procedure

Aggressive vs Minimal Debridement

Primary outcomes

  1. Time to healing

    Time frame: 0-16 weeks

    Time to complete healing as determined by one of the study investigators

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 19, 2019
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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