Coupling Negative Pressure Wound Therapy With Instillation

Burns Clinical Trial

Official title:

Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677166
• Other study ID #: 5200176
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Loma Linda University
• Contact: Stephanie W Holzmer, MD
• Phone: (909) 558-8085
• Email: sholzmer[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.

Description:

Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.

Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.

Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.

Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:

• Instillation solution: normal saline

• Dwell/soak time: 30 seconds

• Cycle Time: 4 hours

• Pressure: 125mmHg

The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who have been offered split-thickness skin graft for treatment of an extremity wound.

Exclusion Criteria:

• Abnormal healing (diagnosed with connective tissue disorder)

• Uncontrolled diabetes mellitus (HgbA1c >9)

Related Conditions & MeSH terms

• Burns
• Ulcer
• Wound
• Wounds and Injuries

Intervention

Device:
• Negative pressure wound therapy coupled with instillation
Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.
• Standard Negative Pressure Wound Therapy
standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (3)

Lead Sponsor	Collaborator
Loma Linda University	3M, Acelity

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nguyen TQ, Franczyk M, Lee JC, Greives MR, O'Connor A, Gottlieb LJ. Prospective randomized controlled trial comparing two methods of securing skin grafts using negative pressure wound therapy: vacuum-assisted closure and gauze suction. J Burn Care Res. 2015 Mar-Apr;36(2):324-8. doi: 10.1097/BCR.0000000000000089. — View Citation

Yin Y, Zhang R, Li S, Guo J, Hou Z, Zhang Y. Negative-pressure therapy versus conventional therapy on split-thickness skin graft: A systematic review and meta-analysis. Int J Surg. 2018 Feb;50:43-48. doi: 10.1016/j.ijsu.2017.12.020. Epub 2017 Dec 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Skin Graft Take at Four Days Post-Operative	percentage of skin graft take at time of wound vac take down (4 days post-op)	4 days from intervention
Secondary	Percentage of Skin Graft Take at Thirty Days Post-Operative	percentage of skin graft take at follow up clinic appointment	30 days from intervention