NCT06006572

Brief Summary

This study aims to analyze the difference in rates of wound complications using two different closure techniques in Direct anterior approach for primary total hip replacement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Wound complications

    Assessed using photographic documentation of the wound

    90 days

  • Participant satisfaction

    assessed using the POSAS (patient and observer scar assessment scale) questionnaire

    90 days

Study Arms (2)

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

ACTIVE COMPARATOR

After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

Procedure: wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

ACTIVE COMPARATOR

After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Procedure: wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Interventions

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years old that will undergo THA via DAA

You may not qualify if:

  • Previous hip arthroplasty surgeries or scars
  • THA secondary to oncologic or traumatic etiologies
  • BMI ≥ 40
  • uncontrolled diabetes (measured by a Hgb A1c above 8)
  • reported allergy to skin adhesive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

March 1, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations