Clinical trial NCT00778947: Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
Official title: Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Reconstruction
Keywords: Breast Reconstruction
Halmonic Scalpel
diathermy
Free Tissue Transfer
Lead sponsor: St Andrew's Centre for Plastic Surgery
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.


Eligibility criteria: Inclusion Criteria:

1. Female patients aged between 18 and 80 years old
2. Able to comprehend, follow, and provide written informed consent.
3. Willingness to comply with study requirements including follow-up visits

Exclusion Criteria:

1. Patients who have a pacemaker
2. Pregnant or breast feeding females.
3. General contraindication for surgery as deemed by the PI (e.g. physically unfit)
4. Patients who smoke
5. Diabetic patients
6. Patients who are receiving permanent analgesics
7. Patients receiving anti-coagulation therapy.
8. Patients with a physical or psychological condition which would impair participation in the study.
9. Participation in any other device or drug study within 90 days prior to enrollment.
10. Planned participation in any other medical device study during the timeframe of this study.

Primary outcomes:
measure: The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.
timeFrame: At surgery
Secondary outcomes:
measure: Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire
timeFrame: At surgery
measure: Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.
timeFrame: 3, 6, 12 and 24 weeks post operation
measure: Rates of post operative infection
timeFrame: post operation for 6 months
measure: Incidence of abdominal (donor site) wound dehiscence
timeFrame: post operation for 6 months
measure: Bleeding complications
timeFrame: intra operation and for 6 months post op
measure: Return to theatre
timeFrame: post operation for 6 months
measure: Incidence of seroma
timeFrame: post operation for 6 months
measure: Post operative drainage from the wound
timeFrame: post operation for 6 months
measure: Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively
timeFrame: 3, 6, 12, and 24 weeks post operation
measure: Number of days of hospitalisation
timeFrame: post operation for 6 months
measure: Re-operation required
timeFrame: post operation for 6 months
Other outcomes:
Locations:
city: Chelmsford
country: United Kingdom
facility: St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,
Study officials:
affiliation: St Andrew's Centre for Plastic Surgery
name: V Ramakrishnan
role: PRINCIPAL_INVESTIGATOR
References: