Method of Securing Skin Graft: A Comparison of Vacuum Assisted Closure Device Versus Bolster Dressing

NCT05831020 | Completed DMC

• 1 other identifier: IRB2125/DUHS/Approval/2021/637
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to compare the outcomes of vacuum assisted closure device versus conventional bolster dressing in securing split thickness skin graft in traumatic wounds; with emphasis on percentage of graft take and postoperative complications like hematoma, seroma and infection of graft site. Two groups were formed with 70 patients in each group. Patients were randomly allocated either to group A(VAC group) or group B(bolster dressing group) and outcomes were assessed on 5th post-operative day when first dressing change was done

Conditions

Skin Graft Detachment

Keywords

Graft take, vacuum assisted, Bolster dressing

Outcome Measures

Primary Outcomes (1)

• Graft take

  Defined as the percentage of the skin graft which is adherent to the recipient wound which is wound size. The area for wound size will be pre-operatively measured using ruler in centimeter square and the area where graft is adherent will be measured in percentage. It will be visually assessed by consultant surgeon at the time of first dressing change

  5th post-operative day or earlier if excessive soakage of dressing

Secondary Outcomes (1)

• Post-operative complications

  5th post-operative day or earlier if excessive soakage of dressing

Study Arms (2)

Group A (VAC group)

ACTIVE COMPARATOR

For Group A, VAC dressing was placed to secure split thickness skin graft. Two sheets of sterilized VAC sponge that was cut to fit the wound contour were placed with a fenestrated tube between the two layers that was secured to the surrounding skin using tincture of benzoin spray and an adhesive dressing (OPSITE). The VAC was placed to intermittent -125 mmHg suction for 2 hours and then decompressed for next 2 hours.

Other: VAC and bolster dressing

Group B (Bolster dressing group)

ACTIVE COMPARATOR

For Group B, Bolster dressing was done to secure split thickness skin graft. The recipient site was bolstered with wet bulky cotton gauze dressing and wrapped with cotton bandage. 0.9% normal saline was used for moisture.

Other: VAC and bolster dressing

Interventions

VAC and bolster dressing OTHER

Bolster dressing- Moist bulky cotton gauze dressing and wrapped with cotton bandage. Vacuum assisted closure (VAC) dressing- A fenestrated tube placed between two sheets of sterilized foam secured to the surrounding skin using adhesive dressing (OPSITE).

Group A (VAC group); Group B (Bolster dressing group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients undergoing skin graft at the Civil Hospital
• aged 18 years to 60 years
• either gender
• ASA grade 1
• Traumatic wounds of size 25 cm2 to 225 cm2 and of greater than 14 days duration with healthy granulation tissue and
• Consenting to participate in the study.

You may not qualify if:

• Patients with signs of wound infection
• Patients with wounds of poor blood supply
• Patients known for allergy or sensitivity to acrylic adhesives.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, 7, Pakistan

Location

Related Publications (7)

• Mohsin M, Zargar HR, Wani AH, Zaroo MI, Baba PUF, Bashir SA, Rasool A, Bijli AH. Role of customised negative-pressure wound therapy in the integration of split-thickness skin grafts: A randomised control study. Indian J Plast Surg. 2017 Jan-Apr;50(1):43-49. doi: 10.4103/ijps.IJPS_196_16.

  PMID: 28615809 BACKGROUND

• Scherer LA, Shiver S, Chang M, Meredith JW, Owings JT. The vacuum assisted closure device: a method of securing skin grafts and improving graft survival. Arch Surg. 2002 Aug;137(8):930-3; discussion 933-4. doi: 10.1001/archsurg.137.8.930.

  PMID: 12146992 BACKGROUND

• Lee SH, Kim YJ. Effectiveness of double tie-over dressing compared with bolster dressing. Arch Plast Surg. 2018 May;45(3):266-270. doi: 10.5999/aps.2017.01424. Epub 2018 May 15.

  PMID: 29788688 BACKGROUND

• Dhillon M, Carter CP, Morrison J, Hislop WS, Currie WJ. A comparison of skin graft success in the head & neck with and without the use of a pressure dressing. J Maxillofac Oral Surg. 2015 Jun;14(2):240-2. doi: 10.1007/s12663-014-0618-8. Epub 2014 Feb 11.

  PMID: 26028841 BACKGROUND

• Azzopardi EA, Boyce DE, Dickson WA, Azzopardi E, Laing JH, Whitaker IS, Shokrollahi K. Application of topical negative pressure (vacuum-assisted closure) to split-thickness skin grafts: a structured evidence-based review. Ann Plast Surg. 2013 Jan;70(1):23-9. doi: 10.1097/SAP.0b013e31826eab9e.

  PMID: 23249474 BACKGROUND

• Kucharzewski M, Mieszczanski P, Wilemska-Kucharzewska K, Taradaj J, Kuropatnicki A, Sliwinski Z. The application of negative pressure wound therapy in the treatment of chronic venous leg ulceration: authors experience. Biomed Res Int. 2014;2014:297230. doi: 10.1155/2014/297230. Epub 2014 Feb 18.

  PMID: 24696847 BACKGROUND

• Yadav S, Rawal G, Baxi M. Vacuum assisted closure technique: a short review. Pan Afr Med J. 2017 Nov 21;28:246. doi: 10.11604/pamj.2017.28.246.9606. eCollection 2017.

  PMID: 29881491 BACKGROUND

Study Officials

• Saira A Chhotani, MBBS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The dressing is opened by principal investigator and then the supervising consultant is called for outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: A two arm parallel assignment, where group A will be VAC group and group B will be bolster dressing group.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: October 21, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)