Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery Clinical Trial
Official title:
Porcine Xenograft Versus Second Intention Healing: a Randomized, Evaluator-blinded Clinical Trial
NCT number | NCT03931746 |
Other study ID # | 18-0715 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 11, 2019 |
Est. completion date | February 1, 2021 |
Verified date | February 2023 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to test whether it is better to allow patients with post- operative wounds on the legs to heal on their own without a covering or to use a porcine xenograft (skin graft that is made from pig cells) to cover the wound during healing. It is currently not known which option is better in terms of the appearance, complication rate or the impact on the patient's quality of life during the healing process. In this location, it is common receive either treatment.
Status | Terminated |
Enrollment | 14 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Over 18 years of age - Able to give informed consent themselves - Willing to return for follow-up visits - Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the lower extremities (including the feet) - Single defect Exclusion Criteria: - Mentally handicapped - Unable to understand written and oral English - Incarceration - Under 18 years of age - Unwilling to return for follow-up - Pregnant women - Wounds less than 8 mm in length - Wounds on the head, neck or digits - Patients in which primary linear closure is recommended |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health Physician Partners Division of Dermatology | Bay Shore | New York |
United States | Northwell Health Physician Partners Division of Dermatology | Lake Success | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score | The primary outcome will be the total score of the POSAS observer scale, assessed at the 3-month (+/- 1 month) follow-up visit by two blinded evaluators who will not be involved in the placement of the porcine xenograft. For each patient, scores from the two blinded investigators will be combined by calculating the mean. The POSAS (Patient and Observer Scar Assessment Scale) is a validated assessment tool used for the assessment of all types of scars by professionals and patients. The observer scale is comprised of 6 items (vascularity, pigmentation, thickness, relief, pliability, and surface area) scored on a scale from 1("like normal skin") to 10 ("worst scar imaginable"). The total score is calculated as the sum of the six items (range, 6-60). | Between 2.70 to 8.75 months | |
Secondary | POSAS Patient Scale Total Score | Study participants will complete the POSAS patient scale at the 3-month follow-up visit. The POSAS (Patient and Observer Scar Assessment Scale) patient scale consists of 6 items assessing patients' subjective opinion of scar quality in terms of pain, itching, color, pliability, thickness, and relief. Each item is scored from 1 (normal pigmentation, no itching, etc.) to 10 ("worst imaginable scar or sensation"). The total score of the POSAS patient scale is calculated as the sum of the six items (range, 6-60). | 3 months | |
Secondary | Healing Time | Healing time will be measured in weeks based on patient's responses to question 1 of the weekly follow-up questionnaire ("Is the wound completely healed (i.e., wound is completely closed with no open areas)?"). For example, a patient who first replies "Yes" to this question on the third weekly follow-up questionnaire will be assigned a healing time of 3 weeks. A more objective measure of healing time would not be feasible given our resources and patient schedule. | Up to 38 weeks | |
Secondary | Ratio of Scar Size to Initial Defect Size | The initial postoperative defect size will be measured by the investigator prior to intervention in terms of length and width using a sterile ruler. Initial defect area will be calculated as length times width. Scar size will be measured in terms of length and width at the 3-month follow-up visit, and scar area will be calculated as length times width. The outcome will be calculated by dividing the scar area by the initial defect area. | 3 months | |
Secondary | Pain Score at 1 Week Following Surgery | Patients' pain scores will be measured based on their response to question 2 of the weekly follow-up questionnaire. Patients will be asked to rate their current pain level at the operative site on a scale from 1 (no pain) to 10 (worst imaginable pain). | 1 week | |
Secondary | Number of Weeks With Pain Score Above 1 | Patients' pain scores will be measured based on their response to question 2 of the weekly follow-up questionnaire. Patients will be asked to rate their current pain level at the operative site on a scale from 1 (no pain) to 10 (worst imaginable pain). | 3 months | |
Secondary | Number of Participants With Infection | Patient's charts will be reviewed at the completion of their 3-month office visit follow-up in order to analyze if they visited the dermatologist between the date of surgery and 3-month office visit and if infection was diagnosed. | 3 months | |
Secondary | Post-operative Bleeding Requiring Physician Intervention | During each of the weekly follow-up questionnaires and during the 3-month follow-up visit, patients will be asked if they have experienced any post-operative bleeding that led to a visit to the physician (yes/no) and if there was any intervention performed by the physician to stop the bleeding (yes/no). The number and percentage of patients who experienced bleeding at any time during the 3-month follow-up period will be reported. | 3 months | |
Secondary | Pain Score of 6 or Higher at One Week | The proportion of patients with a pain score greater than or equal to 6 at the operative site will be assessed at one week following surgery. This will be based on the patient's response to the weekly follow-up questionnaire, with scores ranging from 1 (no pain) to 10 (worst imaginable pain). | 1 week |