This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).
The trial assigns participants to one of three arms: RemovAid+lidocaine patch (n=75), RemovAid+lidocaine injection (n=75) or traditional approach+lidocaine injection(n=75). Complication rates in the different arms will be compared. Efficacy (successful implant removal) will be the secondary comparisons. Finally, pain during removal and duration of removal procedure will be compared. Participants will return to the clinic within 4 weeks of the removal procedure to record the healing process and final interventions (if any).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
Kawempe Referral Hospital
Kampala, Uganda
Number of women who have post-removal complications -
Complications will include unusual level of trauma to the skin (bruising/hematoma), excessive bleeding, use of sutures to repair skin after removal, inability to remove the implant, implant breakage or severing at time of removal, subsequent infection at the removal site, and other complications that may be noted by the investigator
Time frame: 4 weeks
Number of implants that are successfully removed
The number of implants successfully removed i) without breaking the implant and without additional tools (scalpel, tweezers, or forceps), ii) without additional tools, iii) without the additional use of a scalpel.
Time frame: 0-3 hours
Participant pain level
Level of pain as recorded on 10cm visual analog scale from 0cm (No Pain) to 10cm (Worse Pain Imaginable) with higher numbers indicating worse outcomes
Time frame: 0-3 hours
Duration of removal procedure
Number of minutes and seconds need to remove the implant
Time frame: 0-3 hours
Provider feedback on device on whether RemovAid device helped with removal of implant
5-point Likert scale measuring from 1(Strongly Disagree), 2 (Disagree), 3 (Neutral), 4 (Agree), 5 (Strongly Agree) on whether RemovAid device helped with removal of implant with higher scores indicating better outcomes
Time frame: 0-3 hours
Provider feedback on device on ways the product helped or hindered implant removal
Text responses on ways the product helped or hindered implant removal
Time frame: 0-3 hours
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