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

NCT03880331 | Completed DMC

• 1 other identifier: 20193001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Surgical; Wound Heal

Keywords

Secondary intention; Wound care methods

Outcome Measures

Primary Outcomes (1)

• Time to healing

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

  0-16 weeks

Secondary Outcomes (5)

• Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)

  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

  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

  0-16 weeks

• Number of treatment failures

  Through study completion, an average of 6-8 weeks

• Complications

  0-16 weeks

Study Arms (2)

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.

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.

Procedure: Debridement

Interventions

Debridement PROCEDURE

Aggressive vs Minimal Debridement

Aggressive Debridement; Minimal Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Medical Center Peabody

Peabody, Massachusetts, 01960, United States

Location

Related Publications (13)

• 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.

  PMID: 12453138 BACKGROUND

• Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. doi: 10.1016/S0002-9610(03)00307-6.

  PMID: 15147995 BACKGROUND

• 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.

  PMID: 14581817 BACKGROUND

• 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.

  PMID: 18222318 BACKGROUND

• 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.

  PMID: 26979355 BACKGROUND

• 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.

  PMID: 23884238 BACKGROUND

• 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.

  PMID: 20925539 BACKGROUND

• 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.

  PMID: 12451375 BACKGROUND

• 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.

  PMID: 12472488 BACKGROUND

• 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.

  PMID: 1495686 BACKGROUND

• 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.

  PMID: 25372450 BACKGROUND

• 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.

  PMID: 19407619 BACKGROUND

• Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.

  PMID: 20596233 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Interventions

Debridement

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Jeffrey B Tiger, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded investigator will assess photographs of completely healed wounds
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 19, 2019
• Study Start: December 3, 2019
• Primary Completion: July 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Investigator will have access to the results as needed to author the paper.

Locations

US (1)