Back to resultsProspective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Primary Purpose
Wound Surgical, Wound Heal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Debridement
Sponsored by
About this trial
This is an interventional treatment trial for Wound Surgical focused on measuring Secondary intention, Wound care methods
Eligibility Criteria
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.
Sites / Locations
- Lahey Medical Center Peabody
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aggressive Debridement
Minimal Debridement
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to healing
Time to complete healing as determined by one of the study investigators
Secondary Outcome Measures
Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)
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
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
Number of required debridements over the course of healing
Number of treatment failures
Number of wounds that do not heal by 16 weeks
Complications
Including degree of pain (on a scale of 0-10), number of episodes of bleeding, number of infection, and incidence of tumor recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03880331
Brief Title
Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Official Title
Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Surgical, Wound Heal
Keywords
Secondary intention, Wound care methods
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Blinded investigator will assess photographs of completely healed wounds
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aggressive Debridement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimal Debridement
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Debridement
Intervention Description
Aggressive vs Minimal Debridement
Primary Outcome Measure Information:
Title
Time to healing
Description
Time to complete healing as determined by one of the study investigators
Time Frame
0-16 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)
Description
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.
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.
Title
Cosmetic Appearance
Description
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.
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
Title
Number of required debridements
Description
Number of required debridements over the course of healing
Time Frame
0-16 weeks
Title
Number of treatment failures
Description
Number of wounds that do not heal by 16 weeks
Time Frame
Through study completion, an average of 6-8 weeks
Title
Complications
Description
Including degree of pain (on a scale of 0-10), number of episodes of bleeding, number of infection, and incidence of tumor recurrence
Time Frame
0-16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Tiger, MD
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Medical Center Peabody
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Investigator will have access to the results as needed to author the paper.
Citations:
PubMed Identifier
12453138
Citation
Saap LJ, Falanga V. Debridement performance index and its correlation with complete closure of diabetic foot ulcers. Wound Repair Regen. 2002 Nov-Dec;10(6):354-9. doi: 10.1046/j.1524-475x.2002.10603.x.
Results Reference
background
PubMed Identifier
15147995
Citation
Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. doi: 10.1016/S0002-9610(03)00307-6.
Results Reference
background
PubMed Identifier
14581817
Citation
Hess CT, Kirsner RS. Orchestrating wound healing: assessing and preparing the wound bed. Adv Skin Wound Care. 2003 Sep-Oct;16(5):246-57; quiz 258-9. doi: 10.1097/00129334-200309000-00015.
Results Reference
background
PubMed Identifier
18222318
Citation
Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.
Results Reference
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PubMed Identifier
26979355
Citation
Alavi A, Sibbald RG, Phillips TJ, Miller OF, Margolis DJ, Marston W, Woo K, Romanelli M, Kirsner RS. What's new: Management of venous leg ulcers: Treating venous leg ulcers. J Am Acad Dermatol. 2016 Apr;74(4):643-64; quiz 665-6. doi: 10.1016/j.jaad.2015.03.059.
Results Reference
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PubMed Identifier
23884238
Citation
Wilcox JR, Carter MJ, Covington S. Frequency of debridements and time to heal: a retrospective cohort study of 312 744 wounds. JAMA Dermatol. 2013 Sep;149(9):1050-8. doi: 10.1001/jamadermatol.2013.4960. Erratum In: JAMA Dermatol. 2013 Dec;149(12):1441.
Results Reference
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PubMed Identifier
20925539
Citation
Luft HS. Becoming accountable-opportunities and obstacles for ACOs. N Engl J Med. 2010 Oct 7;363(15):1389-91. doi: 10.1056/NEJMp1009380. No abstract available.
Results Reference
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PubMed Identifier
12451375
Citation
Gloster HM Jr. The use of second-intention healing for partial-thickness Mohs defects involving the vermilion and/or mucosal surfaces of the lip. J Am Acad Dermatol. 2002 Dec;47(6):893-7. doi: 10.1067/mjd.2002.125065.
Results Reference
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PubMed Identifier
12472488
Citation
Gohari S, Gambla C, Healey M, Spaulding G, Gordon KB, Swan J, Cook B, West DP, Lapiere JC. Evaluation of tissue-engineered skin (human skin substitute) and secondary intention healing in the treatment of full thickness wounds after Mohs micrographic or excisional surgery. Dermatol Surg. 2002 Dec;28(12):1107-14; discussion 1114. doi: 10.1046/j.1524-4725.2002.02130.x.
Results Reference
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PubMed Identifier
1495686
Citation
Dodson MK, Magann EF, Meeks GR. A randomized comparison of secondary closure and secondary intention in patients with superficial wound dehiscence. Obstet Gynecol. 1992 Sep;80(3 Pt 1):321-4.
Results Reference
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PubMed Identifier
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Citation
Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.
Results Reference
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PubMed Identifier
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Citation
Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.
Results Reference
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PubMed Identifier
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Citation
Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
Results Reference
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Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
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