Wound SurgicalNCT03880331
Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
A study testing Debridement in people with Wound Surgical and Wound Heal, run by Lahey Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Surgical, Wound Heal
- What is being tested?
- Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Medical Center Peabody
Peabody, Massachusetts, 01960
About this study
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.
Read the 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.
- Conditions
- Wound Surgical, Wound Heal
- Being tested
- Debridement
- Keywords
- Secondary intention, Wound care methods
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebridementProcedure or surgery
Aggressive vs Minimal Debridement
| Study group | Role | What they receive |
|---|---|---|
| Aggressive Debridement | Active comparator | 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. Receives: Procedure: Debridement |
| Minimal Debridement | Active comparator | 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. Receives: Procedure: Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
Time to complete healing as determined by one of the study investigators
Measured: 0-16 weeks
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 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
Number of required debridements
Number of required debridements over the course of healing
Measured: 0-16 weeks
Number of treatment failures
Number of wounds that do not heal by 16 weeks
Measured: Through study completion, an average of 6-8 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
Measured: 0-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start3 Dec 2019
- Primary completion1 Jul 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Wound SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Tiger, Lahey Clinic
- Investigators
- Jeffrey B Tiger, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880331
- Sponsor's protocol ID
- 20193001
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 12453138Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. doi: 10.1016/S0002-9610(03)00307-6.
PubMed 15147995Hess 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.
PubMed 14581817Fonder 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.
PubMed 18222318Alavi 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.
PubMed 26979355Wilcox 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.
PubMed 23884238Luft 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.
PubMed 20925539Gloster 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.
PubMed 12451375Gohari 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.
PubMed 12472488Dodson 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.
PubMed 1495686Joo 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.
PubMed 25372450Durani 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.
PubMed 19407619Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
- ClinicalTrials.gov ID
- NCT03880331
- Acronym / sponsor ID
- 20193001
- Conditions
- Wound Surgical, Wound Heal
- Keywords
- Secondary intention, Wound care methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aggressive Debridement | Active comparator | Procedure: DebridementAggressive 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. |
| Minimal Debridement | Active comparator | Procedure: DebridementNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DebridementAggressive vs Minimal Debridement | Procedure or surgery | Aggressive Debridement, Minimal Debridement |
Primary outcome
Time to healing
Time frame: 0-16 weeks
Time to complete healing as determined by one of the study investigators
5 secondary outcomes
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.
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
Number of required debridements
Time frame: 0-16 weeks
Number of treatment failures
Time frame: Through study completion, an average of 6-8 weeks
Complications
Time frame: 0-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 12453138Saap 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.
- Background: PubMed 15147995Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. doi: 10.1016/S0002-9610(03)00307-6.
- Background: PubMed 14581817Hess 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.
- Background: PubMed 18222318Fonder 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.
- Background: PubMed 26979355Alavi 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.
- Background: PubMed 23884238Wilcox 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.
- Background: PubMed 20925539Luft 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.
- Background: PubMed 12451375Gloster 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.
- Background: PubMed 12472488Gohari 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.
- Background: PubMed 1495686Dodson 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.
- Background: PubMed 25372450Joo 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.
- Background: PubMed 19407619Durani 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey B Tiger, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement in people with Wound Surgical and Wound Heal, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (time frame: 0-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880331, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.