Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction

NCT04808765 | Unknown

• 1 other identifier: ZG01012019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.

Conditions

Breast Cancer; Breast Reconstruction

Keywords

breast cancer; closed incision negative pressure wound therapy; Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Postsurgical complications - reported for 60 patients

  surgical site complications

  1 month

• Postsurgical complications - reported for 60 patients

  surgical site complications

  1 year

Secondary Outcomes (5)

• Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast

  1 week after surgery

• Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast

  1 month after surgery

• Objective examination of scar quality

  1 year after surgery

• Subjective examination of scar quality

  1 year after surgery

• Subjective quality of life

  1-2 years after surgery

Study Arms (2)

VAC group

EXPERIMENTAL

A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision

Procedure: Immediate Breast reconstruction

ST group

ACTIVE COMPARATOR

A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision

Procedure: Immediate Breast reconstruction

Interventions

Immediate Breast reconstruction PROCEDURE

immediate mastectomy with breast reconstruction with implants or expanders

Also known as: immediate mastectomy with breast reconstruction with implants or expanders

ST group; VAC group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patients with indications for immediate breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years of age
• indications for immediate breast reconstruction

You may not qualify if:

• pregnancy or lactation,
• use of steroids, use of immune modulators known to affect wound healing;
• tattoos in the area of the incision;
• breast skin conditions such as cutis laxa;

Sponsors & Collaborators

• University in Zielona Góra: lead
• ConvaTec Inc.: collaborator

Study Sites (1)

University in Zielona Gora

Zielona Góra, Lubusz Voivodeship, 65-046, Poland

Location

Related Publications (4)

• Singh D, Lobach V, Holton T. Use of Closed-Incision Negative-Pressure Therapy in Aesthetic Surgery. Plast Reconstr Surg. 2019 Jan;143(1S Management of Surgical Incisions Utilizing Closed-Incision Negative-Pressure Therapy):11S-14S. doi: 10.1097/PRS.0000000000005306.

  PMID: 30586097 RESULT

• Willy C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12.

  PMID: 27170231 RESULT

• Gabriel A, Sigalove SR, Maxwell GP. Initial Experience Using Closed Incision Negative Pressure Therapy after Immediate Postmastectomy Breast Reconstruction. Plast Reconstr Surg Glob Open. 2016 Jul 22;4(7):e819. doi: 10.1097/GOX.0000000000000803. eCollection 2016 Jul.

  PMID: 27536498 RESULT

• Gabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes. Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug.

  PMID: 30324063 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty; Drug Implants

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dawid Murawa, PROF

  University in Zielona Gora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)