Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing

NCT07048184 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: GN23ON401
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the differences in clinical outcomes and health economics between standard absorbent dressings versus Negative Pressure Wound Therapy dressings following the surgical resection of sarcoma tumours.

Conditions

Sarcoma; Negative Pressure Therapy; Wound Complication

Keywords

Sarcoma; Surgery; Wound Complication; Negative Pressure Wound Therapy; NPWT; Dressing; Tumour Resection

Outcome Measures

Primary Outcomes (2)

• Clinical Outcome: The proportion of patients experiencing wound complications

  Measured as the proportion of patients with 1 or more wound complications experienced between surgery and the end of post-surgery treatment (4 months after surgery). This will be a binary endpoint for each patient (yes/no). Types of wound complication include: * Superficial and deep surgical site infections * Dehiscence: partial and complete cases * Other

  From surgery to 4 months post-op

• Health Economic: The incremental cost per complication avoided

  Measured using a breadth of health economic data collected during the course of the study to capture the cost of complications, readmissions, EQ5D-5L questionnaire, recovery times and return to work.

  From surgery up to 4 months post-operatively

Secondary Outcomes (3)

• Change in EuroQoL-5 Dimensions (EQ-5D-5L) (Patient reported outcome measure of a patients perceptions of their overall health)

  Baseline, 28 day post-op and 4 month post-op

• Change in Toronto Extremity Salvage Score (Patient-reported outcome measure of function after limb salvage procedures)

  Baseline and 4 months post-operatively

• Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)

  Baseline and 4 months pot-operatively

Study Arms (2)

Standard Absorbent Dressing

ACTIVE COMPARATOR

Standard Absorbent Dressings for wound closure

Device: Standard Absorbent Dressings

Negative Pressure Wound Therapy Dressing

EXPERIMENTAL

NPWT Dressings will be used for wound closure

Device: Negative Pressure Wound Therapy (NPWT) Dressings

Interventions

Negative Pressure Wound Therapy (NPWT) Dressings DEVICE

During wound closure, skin glue is not permitted as this interferes with the NPWT suction mechanism. The NPWT is a mesh-based dressing that will be applied following the transparent occlusive dressing as per the manufacturer's instructions. Patients assigned to NPWT will have their dressing connected to a suction device (ActiV.A.C.®, KCI) providing a constant negative pressure of 125mmHg and left in situ for between 5 and 7 days. The dressings and suction device are all CE-marked medical devices that are being used within their intended usage.

Negative Pressure Wound Therapy Dressing

Standard Absorbent Dressings DEVICE

The wound will be closed as per the standard surgical technique and the operating surgeon's preference. Following wound closure of sarcoma tumour resection, standard absorbent dressing will be applied as per local protocols and the pre-op plan

Standard Absorbent Dressing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcoma of the upper/lower limb or torso requiring wide local excision, planned marginal excision or amputation
• Able to provide informed consent
• Aged 16 years or over
• Able, and willing, to adhere to scheduled trial procedures and visit schedule

You may not qualify if:

• Previous surgery to planned surgical field
• Contra-indication to surgical excision of the tumour
• Disseminated malignancy on pre-op radiological imaging
• Post-radiation sarcoma
• Allergy to adhesive dressing
• Subjects who, in the opinion of the PI, will be unable to comply with follow-up

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Solventum: collaborator
• Sarcoma UK: collaborator
• CRUK Trials unit Glasgow: collaborator

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Related Publications (6)

• Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.

  PMID: 26313829 BACKGROUND

• Bedi M, King DM, DeVries J, Hackbarth DA, Neilson JC. Does Vacuum-assisted Closure Reduce the Risk of Wound Complications in Patients With Lower Extremity Sarcomas Treated With Preoperative Radiation? Clin Orthop Relat Res. 2019 Apr;477(4):768-774. doi: 10.1097/CORR.0000000000000371.

  PMID: 30811365 BACKGROUND

• Ouyang Z, Trent S, McCarthy C, Cosker T, Stuart R, Pratap S, Whitwell D, White HB, Tao H, Guo X, Maxime Gibbons CL. The incidence, risk factors and outcomes of wound complications after preoperative radiotherapy and surgery for high grade extremity soft tissue sarcomas: A 14-year retrospective study. Eur J Surg Oncol. 2023 Nov;49(11):107086. doi: 10.1016/j.ejso.2023.107086. Epub 2023 Sep 16.

  PMID: 37741042 BACKGROUND

• O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9.

  PMID: 12103287 BACKGROUND

• Shields DW, Razii N, Doonan J, Mahendra A, Gupta S. Closed incision negative pressure wound therapy versus conventional dressings following soft-tissue sarcoma excision: a prospective, randomized controlled trial. Bone Jt Open. 2021 Dec;2(12):1049-1056. doi: 10.1302/2633-1462.212.BJO-2021-0103.R1.

  PMID: 34905941 BACKGROUND

• Nandra R, Hwang N, Matharu GS, Reddy K, Grimer R. One-year mortality in patients with bone and soft tissue sarcomas as an indicator of delay in presentation. Ann R Coll Surg Engl. 2015 Sep;97(6):425-33. doi: 10.1308/003588415X14181254790284. Epub 2015 Aug 14.

  PMID: 26274756 BACKGROUND

Related Links

• UK S. Sarcoma Incidence
• EUROQOL. EQ-5D-5L User Guide 2023

MeSH Terms

Conditions

Sarcoma

Interventions

Negative-Pressure Wound Therapy; Bandages

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Equipment and Supplies

Study Officials

• Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS

  Department of Trauma and Orthopaedics, Glagow Royal Infirmary, NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Soulis, MA

CONTACT

+4401413017184; eileen.soulis@glasgow.ac.uk

James Doonan, PhD

CONTACT

+44 0141 201 6535; james.doonan@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will be fully unblinded due to the nature of the wound dressings used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)