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 : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wound Surgical Wound Heal||Procedure: Debridement||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
|Official Title:||Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||July 2020|
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.
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.
Aggressive vs Minimal Debridement
- Time to healing [ Time Frame: 0-16 weeks ]Time to complete healing as determined by one of the study investigators
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880331
|Contact: Jeffrey B Tiger, MDfirstname.lastname@example.org|
|Contact: Michelle P Curran, RNemail@example.com|
|Principal Investigator:||Jeffrey B Tiger, MD||Lahey Clinic|