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

April 14, 2023 updated by: Saira Ahmed Chhotani, Dow University of Health Sciences
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was conducted at the Department of Plastic and Reconstructive Surgery at Dr. Ruth K.M. Pfau Civil Hospital Karachi from 21st October 2021 to 20th June 2022. Before conducting the study, ethical approval was obtained from Dow University of Health Sciences (DUHS) (IRB-2125/DUHS/Approval/2021/637).

All patients were enrolled via non-probability consecutive sampling. The sample size for the current study was calculated as follows:

Mean graft take for VAC group = 96 ±6 Mean graft take for conventionally treated group = 89±20 (10) Level of confidence = 95% Power = 80% A sample of 140 patients (70 per group) was required to detect mean difference of 7 in graft take between two groups as estimated by using the above parameters through online available calculator Open Epi.

Patients visiting outpatient department and requiring skin graft were admitted to Plastic surgery and recruited into the study with their consent. Study purpose and risk and benefits associated with the procedure were explained to the patient to obtain their consent. Total 70 patients in each group, meeting the inclusion criteria were enrolled. Patients were randomly allocated either to the conventional group or new technique group. Random allocation of patients was done using the SNOSE (sequentially numbered opaque sealed envelope) protocol. Total 140 sequentially numbered opaque sealed envelopes was prepared enclosing the group name with half of the envelop will be enclosing name of group A (VAC group) and other half enclosing the group b (bolster dressing group) and after that envelops was shuffled to ensure randomization.

Skin grafting was performed under general anesthesia. Humby's knife was used to harvest skin graft from donor site. Skin graft was hand meshed and secured to the recipient site circumferentially with absorbable sutures, followed by Tincture of benzoin soaked paraffin gauze layer. For the bolster dressing group, the recipient site was bolstered with wet bulky cotton gauze dressing and wrapped with cotton bandage. 0.9% normal saline was used for moisture. For the Vacuum assisted closure (VAC) Group, 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 at -125mmHg suction and checked for any air leak. Any loss of suction was treated by reinforcing the adhesive dressing over the air leak. The VAC was decompressed and clamped till the patient is shifted back to the ward. Once in ward, The VAC was placed to intermittent -125 mmHg suction for 2 hours and then decompressed for next 2 hours. Bed rest, sling or splint was used for immobilization depending on the location of injury.

Patients were permitted for slight movement for personal hygiene reasons. First dressing change was done on 5th post-operative day. They underwent early change of dressing in case excessive soakage of dressing with blood, serous fluid or foul smelling discharge or pus was present. Dressing of patient was opened on 5th operative day by researcher and then assessed by supervising consultant for percentage of skin graft take and post-operative complications. A pre-designed proforma was designed to collect the data. Patients' data was kept confidential. Medical record no. of patients was tagged with other serial number to assure the confidentiality of the data and only principal investigator had an access to original data.

Data was entered and analyzed by using SPSS version 21. Qualitative variables like gender, socioeconomic status, place of residence, smoking status, medical comorbidities (such as diabetes mellitus and hypertension), graft site, donor site, post-operative complications were presented as frequency with percentages. Quantitative variables such as age, height, weight, BMI, graft size, length of stay in the hospital, percentage of graft take were summarized in terms of mean standard deviation. Effect-modifiers such as age, gender, BMI, smoking status, graft site, graft size, diabetes and hypertension will be controlled through stratification. Post-stratification independent t-test or Mann Whitney U test will be applied to compare percentage of graft take among two treatment groups. Post-stratification chi-square test will be applied to assess difference of post-operative complications among two treatment groups. P-value <0.05 was considered as statistically significant.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 7
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All patients undergoing skin graft at the Civil Hospital

  1. aged 18 years to 60 years
  2. either gender
  3. ASA grade 1
  4. Traumatic wounds of size 25 cm2 to 225 cm2 and of greater than 14 days duration with healthy granulation tissue and
  5. Consenting to participate in the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (VAC group)
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

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).
Active Comparator: Group B (Bolster dressing group)
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft take
Time Frame: 5th post-operative day or earlier if excessive soakage of dressing
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 5th post-operative day or earlier if excessive soakage of dressing
Hematoma, seroma and wound infection will be assessed visually by the consultant surgeon on first dressing change.
5th post-operative day or earlier if excessive soakage of dressing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Saira A Chhotani, MBBS, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB2125/DUHS/Approval/2021/637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To maintain confidentiality of participants, medical record no. of patients was tagged with other serial number and only principal investigator had and will have an access to original data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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